Job Title: Clinical Project Manager
Location: Boston, MA
Company: Rare Disease Biotech
Employment Type: Full-time
Position Summary:
Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase clinical trials. This pivotal role will provide the opportunity to work at the forefront of cutting-edge science, contributing to the clinical development of novel therapies in a fast-paced, collaborative environment. The ideal candidate will be responsible for planning, managing, and executing Phase I and II trials, ensuring they meet regulatory and scientific standards while staying on time and within budget.
Key Responsibilities:
Clinical Trial Management:
- Lead, manage, and oversee all aspects of early-phase (I/II) clinical trials, with a focus on rare disease therapeutic areas.
- Develop and execute study protocols, timelines, budgets, and resource allocation.
- Ensure adherence to clinical trial plans and regulatory guidelines (FDA, EMA, ICH/GCP).
Vendor & CRO Oversight:
- Manage relationships with CROs, clinical sites, and other vendors to ensure quality, timelines, and compliance.
- Monitor vendor performance and resolve any issues related to study execution.
Study Start-Up & Conduct:
- Oversee site selection, initiation, and activation, ensuring all trial sites comply with regulatory and study-specific requirements.
- Collaborate with investigators, study coordinators, and site staff to ensure smooth trial operations.
Budget & Resource Management:
- Manage clinical trial budgets and resources, ensuring cost-effective use of funds.
- Forecast and track study-related expenses, working closely with finance teams.
Compliance & Quality:
- Ensure all trials are conducted in compliance with FDA, ICH/GCP, and company SOPs.
- Prepare for and participate in regulatory inspections and audits.
Cross-Functional Collaboration:
- Act as the primary point of contact for cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and data management.
- Collaborate with research teams and senior leadership to align trial strategies with broader development goals.
Risk Management:
- Identify potential study risks and proactively develop mitigation strategies.
- Report progress and challenges to senior management and provide solutions to ensure timely delivery of project milestones.
Data & Documentation Oversight:
- Ensure that all clinical trial documentation (protocols, consent forms, CRFs, monitoring plans, etc.) is accurate and up-to-date.
- Work with data management teams to ensure timely data collection, cleaning, and analysis.
Qualifications:
Education:
- Bachelor’s or advanced degree (Master's, PharmD, PhD) in life sciences, nursing, or related field.
Experience:
- 5+ years of experience in clinical project management within the biotech, pharmaceutical, or CRO industry, preferably within early-phase studies.
- Experience managing rare disease clinical trials is highly preferred.
- Strong understanding of FDA/EMA regulations, ICH-GCP guidelines, and early-phase clinical trial execution.
Skills:
- Proven ability to manage multiple projects, timelines, and deliverables in a fast-paced environment.
- Strong leadership and problem-solving skills, with the ability to motivate cross-functional teams and external partners.
- Excellent communication skills, both written and verbal, with experience presenting to internal and external stakeholders.
- Highly organized with attention to detail and a strong focus on quality and compliance.
Technical Competencies:
- Proficiency with clinical trial management systems (CTMS), eTMF, and other relevant software.
- Experience with budgeting and resource management for clinical trials.
