Clinical Project Manager

4 weeks ago

Boston, United States Albion Rye Associates Full time

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.

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