Job Closed
This listing is no longer active.
Engineering the extraordinary
Clinical Specialist CRM - Sarasota
Location
United States
Posted
87 days ago
Salary
$72K - $90K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Specialist CRM - Sarasota
Medtronic
We anticipate the application window for this opening will close on - 30 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.Travel Requirements: - Minimum travel of 10% 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. Learn more about our benefits here. 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. Learn more about total rewards on page 6 here. The provided base salary range is used nationally. The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. ABOUT MEDTRONIC Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. 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 about public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, Medtronic will provide reasonable accommodation for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. 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):USA: $72,000.00 - $90,000.00 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. Learn more about total rewards here. https://www3.benefitsolver.com/benefits/BenefitSolverView?DO_NUM=182665432&error_page=errorpage&page_name=public/download_document¤t_page=admin/refcenter/index&session_co_num=30601&CSRF=aa8b608e81c0aa2acc1346278c504be7963ad2607c15b238282af8d3b5ef0007 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.
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Clinical Growth Advisor
CovetrusCovetrus is a technology and services company on a mission to advance the world of veterinary medicine and empower healthcare teams across the companion, large
Covetrus is a global animal-health technology and services company dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We are bringing together products, services, and technology into a single platform that connects our customers to the solutions and insights they need to work best. Our passion for the well-being of animals and those who care for them drives us to advance the world of veterinary medicine. Location: We are actively hiring for this role in multiple markets, including: - Los Angeles, CA - Jacksonville, FL - Detroit, MI - Washington, D.C. - Houston/Austin, TX The Clinic Growth Advisor is fully remote with 75% travel. The Clinic Growth Advisor serves as a trusted partner to veterinary practices, driving adoption of Covetrus technology solutions, improving operational efficiencies, and enhancing customer satisfaction. This role focuses on proactive customer engagement, platform optimization, growth enablement, and risk mitigation, ensuring practices achieve measurable business outcomes and maintain long-term loyalty. This role will also be responsible for the development of strategies necessary to fully optimize our technology solutions with our veterinary practices and effectively communicating the value of workflow efficiencies within their clinic. Key Responsibilities Customer Engagement and Retention - Ensure Satisfaction: Deliver second-level, high-touch, and tailored engagement to optimize the use of Covetrus platforms and enhance customer experience. - Proactive Wellness Checks: Conduct regular wellness checks for all clinics in the assigned region (twice annually) to identify and address concerns, ensure adoption, and gather valuable feedback. - Customer Advocacy: Build trust by understanding customer needs, aligning solutions to their business goals, and providing guidance to improve outcomes with Covetrus tools and services. - Drive measurable outcomes: Increase dollars in same-store growth and reduce the number of deactivations - High touch customers: Strong focus on top-tier or strategically significant clinics to drive partnerships with our technology offerings for our clinics’ long-term success. Platform Adoption and Optimization - Drive Utilization: Guide customers to leverage proactive prescribing, marketing, and auto ship capabilities, ensuring full adoption of Covetrus solutions. - Consultative Approach: Assist practices in integrating Covetrus tools into their workflows to boost efficiency and drive measurable growth. - Configuration and Benchmarks: Help customers understand and utilize platform analytics to achieve baseline benchmarks, ensuring measurable return on investment. Growth and Upselling - Proactive Sales Support: Collaborate with Veterinary Relationship Managers (VRMs) to identify growth opportunities, target underperforming accounts, and drive workflow optimization of the tools - Second-level Demos: Conduct advanced demonstrations of Covetrus solutions to deepen customer understanding and drive faster close rates. - Upsell Opportunities: Identify and promote additional features and complementary solutions, aligning with customer needs to expand their engagement. Financial and Operational Support - Detailed Reporting: Provide customers with financial insights, including usage patterns and recommendations to maximize outcomes. - Payments Assistance: Resolve customer banking and payment-related inquiries, ensuring smooth financial operations. Risk Mitigation and Monitoring - Monitor Account Health: Identify potential risks through data-driven insights and collaborate with VRMs to proactively address concerns. - Retention Strategy: Implement risk mitigation plans to prevent churn and enhance customer retention, ensuring continued engagement with Covetrus solutions. Marketing and Implementation Support - Value Communication: Ensure customers understand and maximize the value of Covetrus solutions through clear communication and alignment with business goals. - Optimization Strategy: Partner with customers to integrate marketing strategies that highlight platform benefits, including new platform features that increase practice growth, efficiencies and client loyalty. Data Management and Reporting - Customer Insights: Gather Voice of the Customer data to inform internal strategies, enhance products, and improve the overall customer experience. Cross-functional leadership - Serve as a conduit between the clinic and product development, service, and data analytics to provide customer feedback on such things as enhancements, tools needed, marketing solutions, and competitive intelligence to continue to drive vRXPro adoption and utilization. - Contribute to product development on needs for our technology suite of products for optimization. Required Qualifications Education: - Bachelor’s degree in business, life sciences, or a related field. Veterinary education or experience is a plus. Experience: - 8+ years in a veterinary practice (e.g., Practice Manager) or related industry role. - Previous experience in account management, customer success, or similar roles in veterinary, healthcare, or technology sectors preferred. - Comprehensive understanding of veterinary industry challenges, trends, and technology solutions. - Adaptability and strong problem-solving skills. - Experience with objection handling. - Must have the ability to follow through to solve customer problems and deliver value. Key Competencies: - Customer Focus: Strong ability to advocate for customer success and retention with a proactive mindset. - Communication Skills: Exceptional interpersonal and presentation skills to engage stakeholders effectively. - Analytical Thinking: Proficient in analyzing customer data to identify insights and improvement opportunities. - Technology Proficiency: Skilled in Microsoft Office Suite and adapting to new technologies. - Collaboration: Demonstrated ability to work cross-functionally with VRMs, TAEs, and other internal teams. - Adaptability: Flexible and resilient in a dynamic, fast-paced environment. - Strong business acumen and executive presence. - Demonstrated ability to influence decision makers - Strong presentation skills, including development and creation of content and materials. - Prioritizes customers based on account risk and potential. Travel Requirements 75% for high profile in person visits to support account team, trade shows Why Join Covetrus? Covetrus is dedicated to transforming veterinary practices through innovative solutions and exceptional service. As a Clinic Growth Advisor, you’ll play a pivotal role in empowering practices to optimize their operations and achieve outstanding results. Join our team and contribute to advancing veterinary care and customer success across the industry. We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program: - 401k savings & company match - Paid time off - Paid holidays - Maternity leave - Parental leave - Military leave - Other leaves of absence - Health, dental, and vision benefits - Health savings accounts - Flexible spending accounts - Life & disability benefits - Identity theft protection - Pet insurance - Certain positions may include eligibility for a short-term incentive plan We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program: - 401k savings & company match - Paid time off - Paid holidays - Maternity leave - Parental leave - Military leave - Other leaves of absence - Health, dental, and vision benefits - Health savings accounts - Flexible spending accounts - Life & disability benefits - Identity theft protection - Pet insurance - Certain positions may include eligibility for a short-term incentive plan Salary may vary depending on factors such as confirmed job-related skills, experience, and location. It is not typical for an individual to be hired at or near the top end of the range for their role. Compensation decisions are dependent upon the facts and circumstances of each case. Sales Positions are eligible for a Variable Incentive. The pay range for this position is as follows: $94,320-$134,760 Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Clinical Research Associate II- Shockwave Medical
Johnson & Johnson Innovative MedicineAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Clinical Research Associate II– Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Research Manager, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication. Essential Job Functions - May participate in study design and study set up activities - May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct - Participate in the review of monitoring visit reports for completeness - Supports development of study training and may provide study site training to site personnel - Provides study training to internal employees as applicable - Assists in development of CRF design, CRF guidelines and supports database development when applicable - Develop study tools and guidelines to be utilized by study sites - Develops basic knowledge of the process used to evaluate and select potential investigators and sites - Develops basic knowledge of the process used to evaluate and select potential vendors as applicable - Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues - Drafts informed consents as applicable - Reviews site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revisions as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand - Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy, facilitates translation as needed - Ensure study records are auditable in-house - Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports - Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies - May be responsible for initiating and tracking quarterly site payments and reconciling study invoices - Communicates status of trial to manager and team - May be responsible for development or revision of SOPs or work instructions - Appropriately represents functional area - Other duties as assigned Qualifications - Bachelor’s degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role - Must have excellent verbal and written communication skills - High attention to detail and organizational skills are necessary - Basic understanding of peripheral and coronary artery disease and therapies preferred - Working knowledge of GCP, FDA, ISO and other applicable regulations - Ability to travel 10-20% domestically and internationally - Experience with EDC Data Management Systems - Ability to work in a fast-paced environment while managing multiple priorities - ACRP or SOCRA clinical research certification preferred - Operate as a team and/or independently while demonstrating flexibility to changing requirements Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration The anticipated base pay range for this position is : $87,000.00 - $140,300.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Clinical Research Associate (Level II) - FSP Oncology- Northeast US-- Fully remote!
Thermo Fisher ScientificThe World Leader In Serving Science
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions Compensation and Benefits The salary range estimated for this position based in New Jersey is $66,800.00–$112,938.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
• Lead and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures. • Lead and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents. • Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications. • Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs. • Contribute to the electronic submission of clinical trial data to regulatory authorities. • Proactively solve problems of statistical complexity. • Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions). • Participate effectively as a key member on clinical study teams. • Provides analytical insight on statistical methodology and advice to internal teams of accordingly. • Keep current with new clinical trial designs and statistical methodology. • As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. • Train junior staff in more complex statistical methodology. • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.



