IQVIA is a publicly-traded healthcare intelligence company founded in 2016 upon the merger of two market leaders: Quintiles and IMS Health. With locations aroun
Senior Site Feasibility Specialist
Location
Poland
Posted
87 days ago
Salary
PLN102.8K - PLN272.5K / year
Seniority
Senior
Job Description
Senior Site Feasibility Specialist
IQVIA
Role Description IQVIA Biotech is seeking a Senior Site Feasibility Specialist to support our growing clinical operations team. In this role, you will lead country-level Site Activation (SA) activities, ensuring timely start-up of investigative sites in alignment with global and local regulations, SOPs, and project objectives. You will serve as a key liaison between sites, internal teams, and sponsors, contributing significantly to the successful launch of clinical studies. Key Responsibilities - Serve as the Single Point of Contact (SPOC) for assigned studies, working closely with investigative sites, Site Activation Managers (SAMs), Project Management, and cross-functional partners. - Perform start-up and site activation activities according to applicable regulations, SOPs, Work Instructions, and project-specific requirements. - Prepare, review, and ensure the accuracy and completeness of site regulatory documents. - Maintain internal systems, databases, and tracking tools with precise project information. - Review and provide input on site performance metrics, offering feedback to management. - Participate in project timeline planning and implement monitoring or contingency measures as needed. - Communicate completion of regulatory and contractual documentation to internal teams. - Track the progress, approval, and execution of regulatory documents, ethics submissions, Informed Consent Forms (ICFs), and Investigator Pack (IP) releases in line with project timelines. - Provide local expertise during initial and ongoing project planning stages. - Perform quality control checks of site-submitted documents. - Engage directly with sponsors on designated initiatives, as needed. Qualifications - Bachelor’s degree in Life Sciences or a related field, or equivalent experience. - Minimum 3 years of clinical research experience, including at least 1 year in a leadership capacity. - Strong understanding of clinical systems, operational procedures, and corporate standards. - Excellent negotiation, communication, and interpersonal skills with the ability to effectively challenge when needed. - Strong organizational skills and the ability to prioritize and manage multiple projects independently. - Knowledge and practical application of GCP/ICH guidelines, and understanding of clinical trial regulatory requirements (local and international). - Familiarity with the drug development process and the regulated clinical trial environment. - Ability to build and maintain effective working relationships with colleagues, managers, and clients. Benefits - Join a mission-driven organization dedicated to improving patient outcomes through innovative clinical research. - Work in an agile environment with the support of global resources. - Opportunity to grow your career while making a real impact. Company Description IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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Sr Clinical Data Abstractor
NateraFounded in 2004 and led by CEO Steve Chapman, Natera is a company in the biotechnology market that offers genetic testing and diagnostics on a global scale. Ope
POSITION SUMMARY: Perform high-quality medical record abstraction by combining proficient-level experiences in data management and software with medical terminology, medical coding, information encoding, and analytical capabilities. Interpret and manage complex clinical patient data for research, quality improvement, and regulatory reporting. PRIMARY RESPONSIBILITIES: - Data Abstraction: Accurately review, interpret, and abstract clinical patient data from various electronic health record (EHR) systems, paper charts, and other source documents in accordance with defined project or research protocols, clinical, data, and technical specifications, and dictionaries. - Coding and Classification: Apply knowledge of medical coding systems (e.g., ICD-10, MedDRA, CPT, HCPCS) and standard of care guidelines, to interpret, classify and categorize abstracted clinical data points from unstructured text to standardized machine readable data in one common database schema. - Electronic Data Capture (EDC): Utilize specialized data management software (e.g., REDCap, registries, and custom built EDC systems) to enter, track, and maintain the integrity of clinical data encoded into queryable databases. - Technical Support: Aid cross-functional teams in translating clinical and data abstraction and encoding requirements. Support prompt engineering and design for all AI and LLM initiatives. - Data Management: Apply and support establishing program specific clinical data management best practices (CGDMP) and good clinical practice (GCP) during the abstraction and encoding process resulting in accurate, legible, contemporaneous, original, attributable, complete and consistent for end-to-end ETL workflows. - Quality Assurance and Control: Apply industry standard best practices for utilizing real-world data for research, quality monitoring, and regulatory reporting using technical and analytical software such as running MACROs and using Excel/Google Sheets functions and formulas, and pivot tables to support ensuring abstracted data are accurate and clinical complete. - Mentoring and Subject Matter Expertise (SME): Conduct peer reviews on medical record data interpreted and encoded by abstraction peers to ensure quality and productivity performance align with the programs expectations. - Protocol Adherence: Maintain strict adherence to all project and research protocols, institutional review board (IRB) requirements, HIPAA regulations, data management best practices (e.g., DAMA, SCDM, ACRP, and SOCRA), and organizational policies regarding patient privacy and data security. - Process Improvement: Participate in the development and refinement of abstraction and quality guidelines, tools, and standard operating procedures. - Daily Operations: Provide timely and accurate daily, weekly, or monthly abstraction submissions, productivity reporting, and actively participate in team meetings and workshops. - Certifications: Maintenance of all relevant clinical or technical licensures. - Other duties and responsibilities to be performed as assigned. QUALIFICATIONS: - Clinical Background: U. S. licensed Nurse, PA-C, NP, or DNP is required with a Master’s degree in health sciences. Strong understanding of medical terminology, disease processes (especially cancer), standard clinical workflows, and genetic testing. - Clinical Experience: Minimum of 4-5 years of experience in clinical data abstraction and medical records review, preferably in cancer, women’s health, rare diseases. - Data Abstraction Expertise: Proven ability to accurately read, interpret, and abstract complex clinical information from various electronic and paper medical record sources. - Data Management Expertise: Direct experience performing clinical data encoding using standard ontologies including but not limited to ICD-10-CM and SNOMED CT. Direct experience performing data mapping, standardization, and harmonization. - Quality and Compliance: Demonstrated commitment to data integrity, quality control processes, and adherence to HIPAA and other data privacy regulations. - Technical Proficiency: Proficient with Microsoft Office Suite or Google Suite, creating pivot tables, generating reports, data analysis, and using clinical data systems or databases common in clinical data abstraction, research, or clinical data management (e.g., fillable forms, ECDs, data registries). - Certifications/Industry Expertise: CCDM, CCRP, ACR-P, or CRA preferred. - Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with clinical and non-clinical teams. - Autonomy: Proven ability to work independently, manage time effectively, prioritize and organize tasks, and meet strict productivity and quality deadlines. - General Expertise: - Possess a high level of initiative and self-motivation. - Capable of working part of a team on high visibility projects and tasks with high rates of communication. - In-depth attention to detail and a fast learner. - Responding to shifting priorities and changes. OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page
Clinical Research Associate Location: Morrisville United States Job Description: Description Experienced Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.
Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.
We anticipate the application window for this opening will close on - 26 Mar 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role.Bring your clinical talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career in clinical and sales support as we engineer the extraordinary and change lives. POSITION DESCRIPTION: Provide technical, educational and sales support to assist the district in meeting assigned Coronary Renal Denervation (CRDN) sales and customer service objectives with a heavy emphasis on supporting CathWorks FFRangio. CRDN seeks collaborative candidates who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. We look for candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. This position will be the customer's first line contact for the CRDN daily operations at assigned accounts. ** This position is a field-based and regional role. Must be able to travel up to 70% of the time within regions** To find all CRDN Clinical Specialist roles available please use #CRDNCS in the key word search at Medtronic Careers. POSTION RESPONSIBILITIES: - Sales Support for CRDN business units and will assist with the implementation of the sales strategy of the remaining CRDN business units. - Support the regional CRDN sales strategy as set forth by the National Sales Director; working with sales representatives and managers of all business units to achieve business plans. - The Clinical Specialist Manager (CSM) and National Sales Director may include primary responsibility for sales if no other sales representative is assigned to the business unit. Technical Support: - Represents Medtronic during procedures and implants of products to provide troubleshooting and other technical assistance. - Receives technical inquiries by telephone. Research solutions to questions or problems (e.g. product selection issues, technical questions about Medtronic CRDN products when appropriate, etc.) Educational Support: - Educates and trains physicians, hospital personnel and office staff on technical matters relating to our products and pacing through conducting and/or coordinating: - 1. One-on-one training sessions - 2. In-service education programs - 3. Seminars and/or outside symposiums - Assist DM, CSM and in-house training department in educating/training new Clinical Specialists and sales representatives. - Provide training and resources for hospital staff to enable them to conduct training for their personnel (“train the trainer”). Sales Support: - During/following cases: - Complete necessary documentation and phone calls (customer service). - Update sales representatives concerning cases. Immediately notifies representatives regarding issues or problems requiring follow-up. - Serves as effective Medtronic representative to physicians and support staff regarding Medtronic products, service, and support. - Maintain current knowledge regarding CRDN, Medtronic programs, products and services and competitive products. - Maintains open, effective communication with all district personnel, customers, and other Medtronic employees - Performs other related duties as assigned BASIC QUALIFICATIONS: IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME - High School Diploma and a minimum 8 years of work experience in healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Associate degree and a minimum 6 years of work experience in the healthcare, field sales or work experience utilizing complex mathematics, mechanical concepts, science, or computing - OR- - Bachelor’s Degree plus 4 years of experience. DESIRED/PREFERRED QUALIFICATIONS (optional): - Relevant industry, healthcare, industry, marketing, or medical education experience considered where there is specific focus on awareness and education or medical project management. - Expertise with Microsoft Outlook, Excel, Word and PowerPoint and system tracking. - Strong project management skills and experience coordinating and executing marketing programs. - Excellent interpersonal, written, and verbal communication skills. - Excellent work ethic - Thorough working knowledge of medical terminology, medical procedures, and the medical device industry. - Excellent customer service skills and problem resolution skills. - Ability to effectively build and maintain positive relationships with peers and colleagues across organizational levels. PHYSICAL JOB REQUIREMENTS: - Continuous verbal and written communication. - Frequent 2-handed lifting of up to 40 lbs. from floor to chair/table and from one to another surface at approximately the same level - Sitting, standing and/or walking for up to eight plus hours per day - Environmental exposures include eye protection, infectious disease and radiation - Ability to wear 7-9 lbs of lead for extended periods of time while in the O.R. - Frequently required to use hands to finger, handle or feel objects, tools or controls - Ability to effectively use a mobile phone, PC, keyboard and mouse - Frequent bending/stooping, squatting and balance - Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer - Ability to travel extensively with ease - Must be able to drive approximately 80% of the time within assigned territory - Environmental exposure to infectious disease and radiation - Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$100,000 - $100,000 The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.



