Clinical Project Manager leading the planning and execution of Global Drug Development studies for Novartis in China. Collaborating with various teams to ensure compliance and timely delivery of studies.
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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