This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Local Study Associate Director - Oncology based in the United States.
This role sits at the heart of clinical study delivery within a country environment, driving end-to-end execution of oncology trials.
It combines strategic oversight with hands-on operational leadership across local study teams.
You will ensure studies are delivered on time, within budget, and in full compliance with regulatory and quality standards.
The position plays a key role in strengthening site performance, patient recruitment, and data quality.
You will collaborate closely with global stakeholders, investigators, and cross-functional partners.
This is a high-impact role in a fast-paced clinical research setting where precision, leadership, and adaptability are essential.
It offers the opportunity to directly contribute to the advancement of innovative oncology therapies for patients.
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.
- Opportunities for career development within global clinical research programs.
- Flexible work arrangements depending on project and business needs.
- Exposure to global oncology studies and cutting-edge clinical development programs.
- Supportive, collaborative, and multicultural working environment.
- Access to continuous learning, training, and professional development resources.