Company
Biotech
LocalStudyAssociateDirector-Oncology
Neural analysis suggests this role is
optimal for Director candidates.
“Local Study Associate Director - Oncology. Skills: Oncology clinical trials, Study team leadership, Regulatory compliance. Lead and coordinate Local Study Teams. Ensure successful delivery of oncology clinical trials”
What You'll Achieve.
Successful delivery of oncology clinical trials
Industry & Context.
Risk identification; Risk mitigation; Issue resolution
Travel nationally and internationally
What They're Looking For.
Must Have
3+ years of experience in clinical development operations, Managing end-to-end trials, Experience in oncology clinical trial management, Knowledge of ICH-GCP guidelines, Knowledge of applicable local regulatory frameworks, Demonstrated leadership ability, Managing cross-functional teams, Managing complex clinical projects, Excellent project management skills, Excellent organizational skills, Excellent prioritization skills, High attention to detail, Ability to manage multiple priorities, Fluency in English, Bachelor’s degree in life sciences or related field, Ability to travel nationally and internationally
Nice to Have
Experience in US CRO or pharmaceutical environments, Additional local language proficiency is a plus, Proficiency with clinical IT systems
What You'll Do.
Lead and coordinate Local Study Teams
Ensure successful delivery of oncology clinical trials
Oversee all trial and site activities
Ensure compliance with ICH-GCP
Ensure compliance with local regulations
Ensure compliance with procedural requirements
Drive patient recruitment strategies
Maintain communication with investigators
Maintain communication with site staff
Manage risk identification
Manage risk mitigation plans
Resolve operational issues
Supervise study progress reporting
Supervise resource planning
Supervise vendor coordination
Supervise stakeholder coordination
Maintain inspection-ready trial documentation
Contribute to continuous process improvement
Mentor junior team members
How You'll Work.
Team & Collaboration
Local Study Teams; Cross-functional teams; Investigators; Site staff; Vendors; Stakeholders
Communication Scope
Interpersonal abilities; Stakeholder management
Process & Methodology
Project management, Organizational skills, Prioritization skills
Full Job Description
## Accountabilities 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. 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; additional local language proficiency is a plus. 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. Benefits: Competitive compensation aligned with experience and industry standards. Comprehensive health, dental, and vision insurance coverage. Opportun
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