Senior Clinical Program Manager

ZipRecruiter; Atlanta (GA); On-site; USD 95,000 - 130,000; Full time

Job summary

A leading company seeks a Senior Clinical Program Manager to oversee and drive clinical studies supporting various business objectives. The successful candidate will manage vendors, ensure compliance with study protocols, oversee budgets, and contribute to regulatory documentation, requiring strong experience in the pharmaceutical or medical device industry.

Qualifications

• Over 10 years in pharmaceutical or medical device industry, with 7+ years in clinical study management.
• Experience across multiple therapeutic areas is advantageous.

Responsibilities

• Ensure study execution complies with quality standards, on schedule and within budget.
• Manage CROs and third-party vendors, providing oversight and support.
• Develop and execute Evidence and Publication Plans.

Skills

Communication

Teamwork

Organizational skills

Problem-solving

Education

Bachelor’s degree in Life Sciences

Master’s degree (preferred)

Job description

Job Title: Senior Clinical Program Manager

Description:

Under the direction of the VP of Clinical Affairs, the Senior Clinical Program Manager will oversee and drive the implementation of multiple clinical studies to generate evidence supporting Business, Regulatory, Marketing, and Reimbursement objectives for VIVEX products. The role includes coordinating the dissemination of evidence through peer-reviewed publications, meeting presentations, and white papers.

Responsibilities:

1. Ensure study execution complies with quality standards (ICH GCP, local regulations, SOPs), on schedule and within budget.
2. Manage CROs and third-party vendors, including selection, negotiation, supervision, and escalation of issues.
3. Provide oversight and support to CROs to resolve study issues promptly.
4. Ensure operational feasibility, considering patient and site burden, timelines, and study needs.
5. Assist in planning and executing clinical trials strategies and operations.
6. Contribute expertise to study protocols and related documents.
7. Manage study budgets and external spending, addressing impacts appropriately.
8. Coordinate with project teams on budgets, enrollment, and study status; act as a point of contact for vendors.
9. Review protocol deviations and monitor outcomes for trend analysis.
10. Assess and mitigate study risks with CROs and vendors.
11. Ensure database timelines and plans are met, linking strategy with tactical plans.
12. Maintain study readiness for inspections and participate in regulatory inspections as needed.
13. Contribute to clinical documents related to drug/biologic/medical device development.
14. Prepare for key regulatory meetings with expert input.
15. Identify and address project risks with mitigation plans.
16. Recruit, train, and monitor investigators and staff for protocol compliance.
17. Develop data presentations for scientific and regulatory purposes.
18. Develop and execute Evidence and Publication Plans, coordinating dissemination efforts.
19. Handle clinical study-related inquiries from healthcare professionals and sales teams.
20. Perform other duties as assigned.

Qualifications:

Bachelor’s degree in Life Sciences or related field; Master’s preferred. Over 10 years in pharmaceutical or medical device industry, including 7+ years in clinical study management. Experience across multiple therapeutic areas is advantageous. Strong communication, teamwork, organizational, and problem-solving skills.

Working Conditions:

Office and laboratory environments.

Physical Requirements:

Prolonged sitting; occasional lifting up to 20 pounds.

Reports To: None (Direct Reports)

VIVEX Biologics is an equal opportunity employer, committed to diversity and inclusion. We comply with ADA regulations to accommodate qualified individuals with disabilities.