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.