Vice President, Clinical Development Operations
J
JobgetherHealthcare Technology
United StatesFull-TimeVp
Salary not disclosed
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Job Details
- Experience
- 13+ years
- Required Skills
- GCPData managementBudget management
Requirements
- Bachelor’s degree in a scientific, life sciences, healthcare, or related discipline; MS, PhD, or PharmD preferred.
- 13+ years of progressive clinical trial operations experience within pharmaceutical, biotechnology, medical device, or related healthcare industries.
- Significant experience managing clinical studies focused on evidence generation and product development.
- 5+ years of experience building, leading, and developing high-performing clinical operations teams.
- Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Demonstrated experience supporting regulatory inspections and maintaining inspection readiness.
- Proven ability to collaborate effectively with Biostatistics, Data Management, Medical Directors, and cross-functional leadership teams.
- Ability to balance scientific objectives, operational priorities, compliance requirements, and business goals.
Responsibilities
- Own the operational strategy, planning, and execution of clinical studies focused on generating high-value clinical evidence.
- Drive performance against key clinical trial metrics, including site activation, patient enrollment, data quality, timelines, and budget objectives.
- Develop and implement operational strategies that improve trial efficiency, reduce complexity, and accelerate evidence delivery.
- Manage resource planning, financial forecasting, and budget allocation to optimize clinical operations performance.
- Partner with Biostatistics, Data Management, and other clinical teams to ensure accurate, timely, and reliable clinical data flow.
- Establish effective workflows for data capture, reconciliation, cleaning, analysis, and database lock activities.
- Lead, mentor, and develop a high-performing clinical operations organization capable of managing a diverse study portfolio.
- Ensure all clinical activities comply with Good Clinical Practice (GCP), ICH guidelines, and applicable global regulatory standards.
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