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The Clinical Trial Operations Manager (CTOM) is responsible for all aspects of clinical trial including key data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets. In this role you will be involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data. The CTOM is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. The CTOM must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders. The CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of Sanofi products.
Provide oversight of a study to ensure progress according to study timelines. Lead the study team (including representatives from CSUs/affiliates/vendors, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical buyers to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor activities and deliverables (i.e., Central Lab, IRT, data management, COPM). Liaise with coding and TIM representatives when applicable. Ensure study progress is aligned with the projections.
Ensure proper documentation/availability. Develop following study documents as the author: Monitoring Plan, Study Communication Plan, study specific procedures and study operational material (e.g. study newsletters, memo, etc) as needed; Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing: eCRF screens, database structure, data loading) and completion guidelines; Co-develop documents with vendors (specifications of central services, scope of work, operational manual, etc) in conjunction with the study team. Review study team-developed documents including ES, protocol, amendments, and WSI (operational sections) , data transfer plan, the Data Review & Surveillance Plan, recruitment and retention plan, committee charters and/or other operational documents as requested to provide operational input (including on-time and high quality). Ensure that clinical and data management standards are followed for the study
Ensure proper collection and validation of data and documentation on a timely manner. Ensure proper oversight and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinate the centralized review of procedures. Perform patient data validation homogeneously and fulfilling required quality standard. Perform DM vendor oversight. Ensure study documentation is properly maintained and archived in the Trial Master File (TMF), relevant e-Rooms and databases as required.
Organize and lead meetings/ TCs with local team representatives to oversee study progress. Train the monitoring team, participate in investigator meetings, organize and lead meetings/TCs with vendors, contribute to data cleaning, data review meetings
Collect, synthesize and report study information. Maintain and provide information for monthly study reports (including enrollment curves, timelines, analysis of the study status and identification of potential risks)
Investigational Medicinal Product (IMP) Management. Collaborate with the Clinical Supplies Platform to validate IMP needs, specifications, packaging, shipment (including resupply) and reconciliation process.
Participate in selection and management of vendors, development/follow-up of the associated budget. Define needs, tasks and responsibilities of external vendors, participate in the BID, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study in collaboration with the Clinical buyers
Develop and manage the study budget. Support the PL in the preparation of the overall study budget (AED). Prepare the overall budget for the AED in collaboration with the PL. Follow-up the study budget during the study, making forecasts and following expenses/ accruals, identify and evaluate complementary needs. Perform final budget reconciliation with vendors at study end
Preparation and oversight of study audits/inspections both internal and external. Ensure preparation and proper responses to audit/inspection reports & consolidation of findings, communicate important observations to the study team and/or DPE and/or TOPM and Team Leader. Develop and implement immediate action plan at global CSU/sites/vendors level if needed
Provide oversight and preparation for FDA pre-approval inspections (PAI). Upon request, prepare and assist in PAI preparation plan with the PAI project team. Utilize designated tools developed to oversee quality (e.g. Polaris BO reports, PAI Tools kit) for an Inspection-readiness approach and to prepare for CSU, Study Teams & DRS meetings to optimize monitoring efficiency & quality.
Mentor/train new comers. Participate, as a delegate to TL, in the training of new CTOMs on therapeutic area and general responsibilities within their function.
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