Clinical Operations Supervisor at Duke Health coordinating patient care and managing personnel needs in Cardiology Diagnostic Unit. Implementing ambulatory health care services and departmental policies.
About the role
- Associate Clinical Operations Leader leading local study teams to manage clinical trials for BioPharma company. Ensuring compliance with regulations and timely delivery of study data in Turkey.
Responsibilities
- Has the overall responsibility for the study commitments within the country and for the timely delivery of data to the required quality.
- Leads Local Study Team consisting of CRA(s), and CSA(s), for assigned study/studies.
- Leads and optimizes the performance of the Local Study Team(s) at the country level ensuring compliance with client Procedural Documents, ICH-GCP, and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- 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.
- Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at the study country level and local websites as required by local laws and regulations.
- Oversees manages, and coordinates monitoring activities from site activation through to study closure at country and site level per the Monitoring Plans.
- Review monitoring visit reports (as required and following Client SOPs) and proactively advise the monitor(s) on study-related matters.
- Performs any required accompanied Site Visits/training visits with study CRAs.
- Ensures timely preparation of country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
- Ensures timely submission of applications/documents to EC/IRB at start-up and for the duration of the study.
- Works together with Regulatory Affairs to ensure timely delivery of applications/documents for submissions.
Requirements
- Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.
- At least 1 year experience as a 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 ICHGCP as well as relevant local regulations.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget, and with required quality.
- Excellent project management skills.
Benefits
- exceptional financial rewards
- training and development
- healthy work/life balance
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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