What are the responsibilities and job description for the Clinical Study Manager position at Vericel Corporation?
Job Description
Job Description
This role will be based full time in our new, state of the art facility located in Burlington, MA. There may be times that a visit to our current Cambridge location will be necessary.
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Clinical professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Clinical Operations Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Clinical Operations Study Manager is responsible for the management of clinical studies in support of Vericel objectives. The role, in close collaboration with Clinical Operations Management, is accountable for achieving successful deliverables, while meeting company and regulatory requirements according to time, quality, scope and within budget.
DUTIES AND RESPONSIBILITIES
- Works cross-functionally with Clinical Affairs, Medical Affairs, Regulatory, Quality, Legal, Customer Care, and R&D colleagues to design, initiate, and manage Vericel-sponsored clinical studies (directly or via CRO).
- Drives the execution of the assigned clinical studies while adhering to target timelines, budget, and quality standards (directly or via CRO).
- Manages clinical studies independently including participation in protocol development, including risk rationales and study design, contributing to CRF development, investigational product supply management, budget / contract negotiations and essential document management.
- Collaborates with Clinical Operations Management to set targets for clinical monitoring staff and ensures the conduct of studies in compliance with project goals.
- Creates and implements study-specific clinical monitoring tools and documents.
- Creates and oversees the study budget and timelines.
- Participates in the site Identification and site management.
- Writes study documentation (e.g., study plans aligned with the protocol)
- Coordinates and supervises clinical monitoring team.
- Collaborates with Clinical Operations Management to provide Clinical Research Associates with project-specific training and have regular meetings with them.
- Participates in the writing and updating of clinical SOPs.
- Ensures compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.
- Conducts and assists with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols.
- Exhibits good understanding of the complete clinical trial lifecycle and has taken studies from synopsis through Clinical Study Report.
- Provides hands-on managing of vendors (CROs, etc.).
- Hands-on managing study and clinical operating budgets.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity / Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state
