Clinical Project Manager
$102,000–$145,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Conduct end-to-end management of global clinical trials from startup through closeout, leading integration of internal and CRO resources while optimizing vendor performance and budgeting. Collaborate with cross-functional teams to deliver studies on time and within budget, ensuring compliance with ICH GCP and protocol requirements. Provide leadership on patient recruitment plans, author key study documents including protocols and informed consent forms, and oversee site monitoring visits to ensure reliable data delivery. Proactively identify risks, develop mitigation strategies, and manage vendor contracts and key performance indicators. Prepare regulatory filings and ensure inspection readiness by maintaining clinical trial master files and supporting site audits. Lead study-specific meetings and drive continuous improvement through training and mentorship of the clinical operations team.
Required Qualifications
- Minimum of 5-8 years of experience in clinical research
- 1-2 years managing trials in the biotech/pharma industry
- BA/BS preferably in a scientific or health-related discipline
- Experience managing global clinical trials and study teams across all stages (startup-closeout) of phase I-III studies
- Strong working knowledge of GCP/ICH and other applicable regulations/guidelines
- Strong preference for tenured experience in the biotech/pharmaceutical industry in late phase clinical trials
- Solid experience and understanding of the challenges of navigating global study startup including the oversight of site startup processes and timelines
- Experience across several complex therapeutic areas
- Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
- Understand clinical study budgets, accruals, and forecasting with experience liaising with Finance as required
- Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
- Enjoy building relationships with CROs, KOLs and site personnel with a willingness to travel to establish and build relationships
- Experience in vendor selection and overseeing studies managed by a CRO
- Strong interpersonal and relationship-building skills; ability to influence and collaborate across functions and levels
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies
- Independently motivated, detail oriented and good problem-solving ability
- Excellent oral and written communication, organizational and planning skills
- Proven ability to manage timelines and budget
- Detail-oriented, a self-starter and comfortable with broad responsibilities in an fast-paced, small company outsourced trial environment
Desired Qualifications
- Oncology experience is a plus
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