Senior Clinical Project Manager

Position:
Senior Clinical Project Manager

Company:
Azurity Pharmaceuticals

Location:
United States, Raleigh, NC

Employment type:
Full-time

Work Arrangement:
Hybrid

Short Summary:
The Senior Clinical Project Manager is responsible for leading the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials, ensuring compliance with regulations and quality standards.

Responsibilities:
- Lead the operational execution of assigned domestic or global, multi-center late phase clinical trial(s).
- Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans.
- Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors.
- Oversee CRO vendors and ensure study excellence.
- Manage clinical development vendors according to vendor oversight plans.
- Ensure compliance with ICH/GCP guidelines/regulations and applicable SOPs.

Requirement:
- Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred).
- 8+ years of Clinical Trial / Project Management experience within CRO, biotechnology, or pharmaceutical organizations.
- Proven leadership of global clinical studies and cross-functional project teams.
- Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.

Benefits:
- Competitive compensation package, including an annual bonus based on company performance.
- Comprehensive health coverage including medical, dental, vision, and prescription.
- Hybrid work model allowing two days from home and three days in the office.
- Retirement Savings Plan (401K) with matching up to 5%.
- Generous time off policy, including up to 15 vacation days annually and five sick/wellness days.
- Tuition reimbursement for professional growth.
- Azurity High Five peer recognition platform.