Clinical Project Manager

Employment Type: Full-time

Position Summary:

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.

• 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.