Job Closed

This listing is no longer active.

Country/Local Clinical Trial Manager – FSP

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

Germany

Posted

73 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Country/Local Clinical Trial Manager – FSP

Parexel

• Responsible for study and country level activities from start up through conduct and study close. • Regional/Country/Study level implementation of Start-up and Site Activation Plans. • Responsible for country/study level Recruitment Strategy. • Responsible to support the development of study level plans. • Communication with the local team and internal stakeholders and CRO partner to ensure efficient and timely study delivery. • Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables. • Able to work independently and exercise their own judgement.

Job Requirements

  • Minimum of 5 years of relevant clinical trial management experience.
  • Excellent leadership, communication, and organizational skills.
  • Able to multi-task under limited direction and on own initiative.
  • M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential.
  • Prior and demonstrable experience working at a senior level within Study start up preferred.

Benefits

  • Flexible work arrangements
  • Professional development opportunities

Related Categories

Related Job Pages

More Clinical Research Jobs

Full TimeRemoteTeam 10,001+H1B Sponsor

Job Title Clinical Solution Specialist - Patient Monitoring (Field: North Dakota/South Dakota) Job Description Bring your passion for patient care and technology to this role where you’ll be responsible for providing clinical customer support as the clinical application knowledge expert. You’ll facilitate solutions design, optimization, configuration, and delivery of Philips Hospital Patient Monitoring (HPM) products to ensure a quality customer experience. Your role: - Serving as a clinical resource to Philips HPM customers, working closely with the field service, sales, and project management organizations throughout a multiphase implementation and go-live process – establishing and maintaining strong working relationships with key internal partners and customers to enable a successful implementation team. - Understanding customer goals and developing plans to support clinical solutions implementation and usage – delivering clinical services to customers that are consultative, advanced, and focused on workflows and optimization. - Managing the clinical aspects of an implementation to include assessing workflows, evaluating education needs, creating education plans, determining custom configurations requirements, planning and delivering equipment and application education, supporting first customer use, encouraging ongoing adoption of change, and optimizing use of complex monitoring solutions. - Understanding the clinical implications of technical implementations (including networks and clinical informatics systems); applying product and clinical knowledge to troubleshoot and solve problems. - Approximately 90% travel across the district is required. The average driving time is 1-4 hours daily. Occasional overnight stays and travel by air/train/bus may be required. Further support across the zone is required, and occasional national travel may be required. You're the right fit if: - You’ve acquired 4+ years of experience as a Registered Nurse in a hospital environment. Prior clinical training and adult education delivery experience is highly preferred. - Your skills include experience in an Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), Operating Room (OR), Neonatal Intensive Care Unit (NICU), and/or Pediatric Intensive Care Unit (PICU) settings. Knowledge of Philips IntelliVue monitoring equipment and applications preferred. - You have a Bachelor of Science in Nursing degree or equivalent licensure to practice nursing (Registered Nurse); must be able to provide verification for current/active license. Certified Technical Trainer Plus (CTT+) and/or Virtual Certified Technical Trainer Plus (VCTT+) is preferred. - You’re passionate about technology and education related to patient care. - You have excellent verbal and written communication and presentation skills. - You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. - You must be able to: - Work in an office/home office and/or remote setting, as well as in a hospital/healthcare environment; adhere to requirements. - Work flexible hours (based on business needs). - Wear all required personal protective equipment. - May be required to comply with vendor credentialing. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is a field role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. - Learn more about our business. - Discover our rich and exciting history. - Learn more about our purpose. - Learn more about our culture. Philips Transparency Details The annual pay range for this position in ND and SD is $90,000 to $143,000. This role also includes company fleet/car, training, and advancement opportunities. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation such as an annual incentive plan, sales commission, or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in North Dakota (preferably in proximity to Fargo) or South Dakota (preferably in proximity to Sioux Falls). This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

United States
$90K - $143K / year
St. Luke's University Health Network logo

Clinical Triage Specialist (RN) - Rheumatology/Infectious Disease/Pulmonary (PA & NJ Residents Only)

St. Luke's University Health Network

Headquartered in Bethlehem, Pennsylvania, St. Luke's University Health Network - SLUHN is a nationally recognized nonprofit network of health organizations, hos

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Triage Specialist (CTS) (RN) - Access Center will compassionately deliver an exceptional patient experience and provide clinical support to CTS-MA team members by serving as a clinical resource. The CTS-RN is responsible for using nursing judgment in answering/returning patient calls related to direct care provided by the practices. When appropriate, the caller’s symptoms will be assessed and triaged using approved nursing protocols and guidelines to assist in obtaining the appropriate level of care and/or self-care advice. JOB DUTIES AND RESPONSIBILITIES: - Answers telephones, prioritizes clinical triage calls, follows clinical protocols, and coordinates services, as needed. - Verifies patient demographic information and accurately enters the updated information into electronic health record. - Serves as an escalation point for clinical patient issues and other POD team members requiring clinical support, and provides clinical advice based on clinical protocols and procedures. - Manages and responds to escalated electronic patient messages whenever not answering inbound patient calls and uses clinical judgment to prioritize and accommodate patients. - Creates a positive patient experience at every encounter, attempting to independently resolve any issues or concerns of the patient at the time of the phone call, within the scope of the role. - Consistently meets productivity, schedule adherence, and quality standards as set by the Access Center. - Utilizes all resources and guidelines at his/her disposal to effectively assess, prioritize, advise, schedule appointments, or refer calls when necessary to the appropriate medical facility or personnel. - Accurately documents symptoms/complaints, nursing assessment, advice provided and patient/caller response. - Partners with other Access Center teams/PODs and respective practice clinical team on behalf of the patient to assist with clinical concerns, medication refills, or scheduling appointments. - Other duties as assigned. EDUCATION: Graduate of an accredited nursing program. Active Registered Nurse licensure in the state of Pennsylvania and New Jersey or other nursing compact state and other states as deemed necessary by state law. TRAINING AND EXPERIENCE: - Minimum 2 years recent clinical experience in a physician office, home health, critical care and/or emergency room is required. - Strong communication skills - Focused on compliance - Demonstrates continuous growth - Quality-driven - Service-oriented - Excels at time management - Strong problem-solving skills Ability to work from home in accordance with the Network Work from Home Policy if needed. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.

United States
Syneos Health logo

CRA II, BKK, Thailand (remote) - Fixed term CRA

Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, we have worked with: 94% of all Novel FDA Approved Drugs. 95% of EMA Authorized Products. Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Full TimeRemoteTeam 10,001+H1B Sponsor

CRA II, BKK, Thailand (remote) - Fixed term CRA Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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. 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.

Thailand
Job Closed
Full TimeRemoteTeam 10,001+Since 1888H1B Sponsor

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Title Clinical Specialist III, DBS - Louisville, KY Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year - An excellent retirement savings plan with high employer contribution - Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Neuromodulation Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Opportunity As a member of the sales territory team, the Clinical Specialist III, DBS, will demonstrate a comprehensive understanding of principles, concepts, practices and standards related to the therapies in which they support. The incumbent will work in a highly matrixed, geographically diverse environment under general direction with clinical and sales teammates to identify and capitalize on sales opportunities by creating competency, comfort, and expertise with Abbott therapies among physicians, support staff and customers. The incumbent will develop solutions to complex problems, perform work that involves a high degree of independence, and exercise sound judgment in planning, organizing, and executing work while continually seeking to improve territory efficiency. What You’ll Work On - Leads revenue generating projects to support account ownership - Develops and maintains in-depth knowledge of assigned accounts and customers, including competitor activity - Demonstrates high quality service and clinical competency to accounts - Deliver educational projects as directed - Trains new Clinical Specialists - Provides technical, clinical, and programming assistance primarily in support of Territory Managers - Assists Territory Managers in after-hours call support and activities - Integrates into accounts, builds trust, and establishes strong rapport with customers - Demonstrates proficiency in complex programming and case support - Works seamlessly with Territory Managers allowing them increased selling time - Fosters high trust relationships with colleagues including the regional teams and area leadership - As directed by management, contacts, visits and interests clients and potential clients in the company’s products while addressing any client questions and concerns - Provides medical professionals with sales support, information, and training on the use of company products and with staff education, in-services and technical troubleshooting - Conducts evaluations and develops sales strategies for capital equipment opportunities within accounts - Collects and studies information about new and existing products and monitors competitor sales, prices and products - Provides feedback to providers both within operating room setting and outside operating room setting on the directions for use specific to implantable devices - Uses clinical expertise to identify customer training and in-service needs with the goal of increasing customer usage, comfort and understating of the complete product line - Attends trade shows where new products and technologies are showcased; meet other sales representatives and clients to discuss new product developments - Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments - Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Required Qualifications - Associates degree, Technical certification or an equivalent combination of education and work experience. - 5 or more years of experience working with patients in a clinical setting - 3 or more years of experience working in the medical devices industry, including some experience with inventory management - Exceptional clinical competence - Ability and willingness to travel within assigned area on a regular basis(% of travel varies by area) - Capable and willing to work an unpredictable schedule that may change on short notice - Excellent verbal, written and presentation skills with the ability to effectively communicate at multiple levels and to large groups within and outside the organization Preferred Qualifications - Prefer bachelor’s degree in biomedical engineering or related field Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: NM Neuromodulation LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

United States
$78K - $156K / year