Local Study Associate Director - Oncology
Based in the United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 3+ years
- Required Skills
- Project Management
Requirements
- Minimum 3+ years of experience in clinical development operations managing end-to-end trials within CRO or pharmaceutical environments, ideally in the US.
- Proven experience in oncology clinical trial management.
- Strong knowledge of ICH-GCP guidelines and applicable local regulatory frameworks.
- Demonstrated leadership ability in managing cross-functional teams and complex clinical projects.
- Excellent project management, organizational, and prioritization skills.
- Strong communication, interpersonal, and stakeholder management abilities.
- High attention to detail with the ability to manage multiple priorities in a fast-paced environment.
- Fluency in English required.
- Bachelor’s degree in life sciences or a related field (or equivalent qualification).
- Ability to travel nationally and internationally as required.
- Strong ethical standards, adaptability, and proficiency with clinical IT systems.
Responsibilities
- Lead and coordinate Local Study Teams (CRAs, CSAs) to ensure successful delivery of oncology clinical trials at country level.
- Oversee all trial and site activities including feasibility, site selection, activation, monitoring, close-out, and documentation archiving.
- Ensure compliance with ICH-GCP, local regulations, and applicable procedural requirements throughout study execution.
- Drive patient recruitment strategies and maintain strong communication with investigators and site staff.
- Manage risk identification and mitigation plans while proactively resolving operational issues.
- Supervise study progress reporting, resource planning, budgeting, and vendor/stakeholder coordination.
- Support audits, inspections, and maintain inspection-ready trial documentation (including eTMF).
- Contribute to continuous process improvement and mentor junior team members.
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