Manager, Clinical Operations - FSP
New
Based in the United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- Minimum of 5+ years of clinical research experience
- Required Skills
- Project ManagementGCPMicrosoft OfficeBudget management
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related scientific discipline.
- Minimum of 5+ years of clinical research experience in CRO, biotech, or pharmaceutical environment.
- 2–3 years of experience leading aspects of global clinical trials.
- Strong understanding of Good Clinical Practice (GCP) and global clinical trial regulations.
- Experience working with CROs and managing vendor relationships.
- Ability to manage budgets, timelines, and operational deliverables across multiple studies.
- Experience with protocol development, ICFs, CRFs, and CSRs.
- Strong analytical, financial, and decision-making skills.
- Strong communication, leadership, and stakeholder management skills.
- Proficiency in Microsoft Office tools.
Responsibilities
- Manage and coordinate clinical trial operational activities across assigned studies.
- Oversee CROs and external vendors, including selection and performance management.
- Contribute to trial-level operational strategy and protocol planning.
- Develop and maintain key study documents like ICFs and operational plans.
- Monitor study progress and resolve issues regarding enrollment and regulatory submissions.
- Collaborate with cross-functional teams to support study execution.
- Support budget development, forecasting, and financial tracking.
- Ensure inspection readiness and drive risk mitigation planning.
- Drive process improvement initiatives.
- Support onboarding and mentoring of team members.
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