Regional project manager
Job Title: Senior Regional Project Manager
Job Description We are seeking a dedicated and experienced Senior Regional Project Manager to join our dynamic BioPharma group. This role is pivotal in providing strategic oversight and day-to-day management of clinical trials at the US level, collaborating with global teams to ensure successful study execution. Responsibilities- Assume overall responsibility for study commitments within the US, ensuring timely delivery of high-quality data.
- Lead and optimize the performance of the Local Study Team, ensuring compliance with procedural documents, ICH-GCP, and local regulations.
- Conduct clinical and operational feasibility assessments for potential studies.
- Coordinate the site selection process, including initial Site Quality Risk Assessment and Site Qualification Visits.
- Ensure timely submission of applications and documents to IRB and Regulatory Authorities.
- Prepare and maintain accurate study budgets and financial agreements.
- Oversee monitoring activities from site activation through study closure.
- Identify and resolve complex study issues and risks.
- Organize and lead regular Local Study Team meetings.
- Report study progress to Global Study Leaders and stakeholders.
- Contribute to patient recruitment strategies and collaborate with investigators.
- Participate in training and mentoring new team members.
- Ensure study documents are ready for archiving and regulatory inspections.
- Provide input for process development and improvement.
- 5+ years of hands-on project oversight experience.
- 2+ years as a Project Manager or Clinical Research Associate.
- 2+ years of experience in budget build-out and negotiations.
- Bachelor's degree in a related field.
- Strong knowledge of ICH-GCP guidelines and local regulations.
- Excellent project management, team building, and interpersonal skills.
- Proficiency in spoken and written English.
- Prior experience with Veeva Clinical Vault.
- Ability to lead and motivate cross-functional teams.
- Good negotiation skills.
- Adaptability to work with IT systems.
- Ability to travel nationally and internationally as required.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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