Local Study Associate Director – Oncology
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Job Description
Local Study Associate Director leading Local Study Teams in Oncology clinical trials at Parexel. Ensuring compliance, quality, and timely delivery of study commitments at country level.
Responsibilities:
- Leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines.
- Ensures that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports and pro-actively advises the monitor(s) on study related matters.
- Communicates and co-ordinates regularly with National Co-ordinating Investigator on recruitment and other study matters.
- Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Requirements:
- Minimum 3 years of experience in Development Operations leading clinical trials end to end in the US in a CRO or Pharma organization.
- Direct experience in Oncology clinical trial management.
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs).
Benefits:
- Health insurance
- Professional development opportunities
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