Sr. Clinical Project Manager
About The Position
The Senior Clinical Project Manager leads and manages complex clinical studies, demonstrating advanced knowledge of clinical operations methodologies, strong organizational and leadership capabilities, and strategic insight. This role provides operational direction, oversight, and executional excellence to ensure clinical trials are delivered on time, within budget, and in compliance with GCP, ICH, and FDA regulations. The Senior Clinical Project Manager works cross-functionally to align study objectives with program goals and contributes to process improvement initiatives within a fast-paced, small-to-midsize biotech environment.
Requirements
- Bachelor’s degree in health science or related field required; advanced degree preferred.
- Minimum of 8 years of experience in clinical research, with proven management of complex global clinical trials.
- Extensive experience leading high-volume and multi-site studies, demonstrating operational and strategic oversight.
- Strong understanding of GCP, ICH, and FDA regulatory requirements.
- Proactive and independent vendor management experience, including risk identification and mitigation.
- Demonstrated ability to lead cross-functional teams and influence decision-making across multiple stakeholders.
- Excellent verbal, written, and presentation communication skills with strong attention to detail.
Nice To Haves
- Experience in oncology or rare disease clinical programs preferred.
- Proficiency with clinical trial management systems (CTMS), eTMF, and EDC platforms.
- Strong financial acumen with experience managing study budgets and contracts.
- Ability to thrive in a fast-paced, small-to-midsize biotech environment with a hands-on approach.
- PMP certification or equivalent project management training preferred.
Responsibilities
- Lead the planning, execution, and delivery of clinical trials within specified quality, time, and cost parameters. Oversee CFT performance, ensure operational alignment with Clinical Operations program objectives, and manage multiple studies concurrently.
- Provide leadership and guidance to cross-functional study teams (CFTs), fostering collaboration, accountability, and problem-solving across functions. Mentor and delegate responsibilities to support staff as appropriate.
- Lead interactions and negotiations with CROs and vendors to ensure adherence to contractual obligations, budget, and study timelines. Proactively identify and mitigate operational risks to ensure high-quality deliverables.
- Evaluate current methodologies and identify opportunities for greater efficiency and effectiveness across clinical operations processes and systems.
- Communicate study progress, challenges, and outcomes to internal stakeholders, maintaining transparency and alignment across program leadership and clinical operations management.
- Other duties and responsibilities as assigned.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
