Location: Seaport MA: 2-3 Times per week!
Overview:
An innovative biopharma company specializing in rare diseases is seeking a Clinical Project Manager (CPM) / Senior CPM to provide operational leadership for clinical trials. This role includes oversight of protocols, cross-functional teams, and vendor partnerships to ensure adherence to timelines, budgets, and regulatory requirements. Ideal candidates will demonstrate critical thinking, adaptability, and leadership in managing complex clinical projects.
Key Responsibilities:
- Lead cross-functional study teams to deliver trials on time, within scope, and budget.
- Oversee site and vendor selection, feasibility assessments, and contract negotiations.
- Manage study timelines, enrollment forecasts, and patient recruitment plans with risk mitigation strategies.
- Develop and oversee monitoring and vendor management plans, including site visits and performance reviews.
- Coordinate with internal and external teams to ensure accurate data collection, review, and submission for interim analyses and database locks.
- Maintain and oversee the Trial Master File (TMF) in compliance with regulatory requirements.
- Contribute to the development and review of clinical protocols, informed consents, monitoring plans, and study reports.
- Support audits, corrective action plans, and ensure adherence to ICH/GCP guidelines and FDA regulations.
- Mentor junior staff and participate in process improvement initiatives within Clinical Operations.
Qualifications:
- Education: Bachelor’s degree in a scientific discipline preferred (advanced degree a plus).
- Experience: 4–7 years in clinical trial management with sponsor-side experience across various trial phases.
- Strong knowledge of ICH/GCP guidelines and FDA regulations.
- Experience managing vendors, CROs, and leading cross-functional teams.
- Critical thinking and problem-solving skills with a strategic and proactive mindset.
- Proficiency in Microsoft Word, Excel, and Project.
- Strong interpersonal and negotiation skills with a collaborative approach.
About the Company:
This clinical-stage biopharma company is pioneering treatments for rare diseases affecting bone health and blood vessel function. Their lead program focuses on the PPi-Adenosine Pathway to address significant unmet medical needs through innovative enzyme replacement therapies.
Why Join Us?
- Opportunity to lead impactful studies in rare disease therapeutic development.
- Work in a collaborative, patient-focused environment.
- Contribute to groundbreaking advancements in addressing significant health challenges.
