Clinical Operations Manager
2 days ago
Parexel International is seeking an experienced professional to fill the role of Associate Clinical Operations Leader. The ideal candidate will have a strong background in clinical operations, with experience leading local study teams and ensuring timely delivery of data according to plan, budget, and quality standards.
About the Role:
The Associate Clinical Operations Leader will be responsible for leading local study teams, identifying and qualifying sites, and ensuring compliance with client procedural documents, international guidelines such as ICH-GCP, and local regulations. This includes coordinating site selection, performing initial site quality risk assessments, and conducting site qualification visits.
Responsibilities:
- Has overall responsibility for study commitments within the country and ensures timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s) and CSA(s) for assigned study/studies.
- Leads and optimizes performance of Local Study Team at country level ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
- Ensures clinical and operational feasibility assessment of potential studies is performed to highest quality.
Requirements:
- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.
- At least 1 year experience as Lead CRA, Clinical Trial Leader, or Project Leader.
- Minimum 3 years of experience in Development Operations (CRA, SCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Experience in oncology trials.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
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