Sr Clinical Project Research Manager
New
Based in United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- GCPStakeholder managementBudget management
Requirements
- Bachelor’s degree or equivalent experience.
- At least 5+ years in clinical project management within a CRO environment.
- Proven experience managing global clinical trials, ideally including observational studies.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Experience supervising project teams and mentoring junior staff.
- Ability to manage multiple complex projects simultaneously (typically 2–3 studies).
- Excellent communication, presentation, and stakeholder management skills.
- Strong problem-solving abilities with a proactive, solution-oriented mindset.
- Experience preparing or contributing to clinical protocols, consent forms, and regulatory documentation.
- Ability to manage budgets, timelines, and contract deliverables effectively.
- Willingness to travel approximately 10% as needed.
Responsibilities
- Serve as primary sponsor contact for all study-related activities from start-up through close-out.
- Lead cross-functional project teams to ensure delivery of study milestones, timelines, and budgets.
- Develop and oversee operational plans including communication, monitoring, training, compliance, and project timelines.
- Coordinate investigator meetings, site engagement, and recruitment of qualified investigators.
- Supervise project management staff (APMs/PMs) and ensure accurate, timely execution of deliverables.
- Monitor project progress, budgets, and contractual milestones, ensuring alignment with sponsor expectations.
- Support protocol development, CRFs, regulatory documentation, and other key study deliverables.
- Maintain audit-ready project documentation and support sponsor or regulatory inspections.
- Lead internal and client meetings, including project updates, bid defenses, and governance reviews.
- Drive issue resolution, risk mitigation, and continuous process improvement initiatives.
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