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- Mansfield, MA
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Clinical Project Manager
Cardinal Health • Mansfield, MA
Posted 1 day ago
Job Profile and Summary:
The Clinical Project Manager will be responsible for the development and implementation of device clinical trials and to ensure the safety of patients/subjects, the quality and integrity of data, and the proper management of study procedures according to ICH and GCP regulatory guidelines and Standard Operating Procedures. This individual will be able to work under minimal supervision, and provide clinical guidance, strategy, and support for the development of new technologies, new products, extended product claims, and post-market clinical research and surveillance. This individual will participate in all aspects of ongoing clinical research programs by planning, developing, and writing clinical protocols; budgeting; recruiting and training investigators; interfacing with investigators, site coordinators, field clinical personnel, and sales representatives; analyze clinical progress reports for scientific and technical accuracy, and; prepare clinical study reports and IRB/EC submissions.
This position interfaces with R&D, Marketing, Regulatory, Legal, and Medical Affairs, as well as various healthcare professionals, biostatisticians, clinical operations, and other consultants.
Essential duties and responsibilities:
1. Serve as a clinical project manager for evidence generation projects supporting product development, regulatory submissions, and post-market surveillance requirements.
2. Serve as Clinical Affairs representative on assigned project teams.
3. Provide clinical and technical feedback to product development teams during project team meetings.
4. Maintain Standard Operating Procedures for the department as assigned by management.
5. Design and develop study protocols, case report forms, and informed consent forms to produce sound and thorough data to support the approval process for domestic and international submissions; seek input as needed from R&D, Marketing, Medical Affairs, and Regulatory Affairs.
6. Select, interview, and recruit investigational sites and investigators to participate in clinical studies.
7. Prepare for and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites to ensure study requirements are being fulfilled, as required. Ensures adherence to study timeline and budget.
8. Establish and maintain effective relationships with external healthcare professionals/physician advisors and clinical investigators and applicable research staff.
9. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements.
10. Provide support including technical and scientific guidance to investigators and study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials.
11. Maintain clinical project files to ensure compliance with internal procedures and Federal regulations.
12. Assist in the preparation of Institutional Review Boards (IRB) submissions for clinical studies.
13. Prepare budgets for assigned clinical studies.
14. Prepare periodic project status updates.
15. Assist in data analysis and preparation of clinical reports.
16. May prepare for and participate in meetings with regulatory agencies (FDA) as required.
1. A minimum of three (3) years of scientific, technical or clinical research experience required
2. Experience in the Code of Federal Regulations (CFR) for conducting clinical research trials is required
3. Medical device experience is preferred
4. Investigational Device Exemption (IDE) experience is preferred
5. Solid understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, and knowledge of global clinical trial regulations is required
6. Experience with Good Laboratory Practice (GLP), or Good Manufacturing Procedures (GMP) is preferred.
7. Prior experience in all facets of clinical studies is preferred
8. Strong technical or clinical background is required.
1. Support new product development and business critical clinical evidence needs by conducting assigned clinical projects for the medical device franchises within the Medical Solutions business at Cardinal Health.
2. Work collaboratively with Clinical Affairs and cross-functional partners (e.g., R&D, Marketing, Regulatory Affairs, Medical Affairs, Quality, Compliance, Legal), ensuring alignment of clinical project needs and objectives.
3. Develop clinical study protocols, informed consents, Investigator Brochures, other required study materials
4. Plan study budgets, work with investigational sites and internal resources to execute study agreements, vendor contracts and payments.
5. Ability to draft study reports as needed; annual reports, close-out reports, final clinical study reports, as well as clinical sections of regulatory submissions such as 510(k), etc.
6. Ensure registration of clinical studies where required (www.clinicaltrials.gov or similar) from study initiation through posting of results
7. Keep management informed of study status and progress; communicate issues and developments effectively
8. Ability to coordinate and lead multiple projects simultaneously.
9. Proactive with a sense of urgency in managing job responsibilities
10. Effective written and verbal communication skills in the area of technical/clinical applications.
Bachelor’s Degree in Biological Science or related discipline
Excellent written and oral English communication skills
Knowledge and proficient use of Microsoft Office Suite Applications
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.