1. Provide oversight of a study to ensure progress according to study timelines.
CTOM(Trial Management Track) is the leader of clinical trial team (CTT) (including representatives from CSUs / affiliates / CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) and responsible for the operational aspects of the study.
Liaise with the feasibility manager to review and assess country feasibility.
Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors’ specifications and oversee vendor activities and deliverables (i.
e., Central Lab, IVRS, data management, monitoring Meeting Planner).
Liaise with coding and TIM representatives when applicable.
2. Develop and manage the study budget
Develop study budget in collaboration with clinical purchasing department, local CSU (clinical study unit), UMO (Unit management office), review and validate country study budget.
During study conduct, review and track budget spending and perform monitoring on study budget and make complementary budget if needed.
3. Select, set up and manage vendors
Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done in collaboration with the Clinical Purchasing department.
Closely work with vendors to set up central services on time and in high quality in conjunction with the CTT and provide oversight during study conduct to ensure study needs fullfiled.
4. Ensure proper study documentation
Develop following study documents as the author : Monitoring Plan, Study Communication Plan, study-specific procedures and study operational material (e.
Co-develop documents with vendors (specifications of central services, scope of work, operational manual, etc) in conjunction with the CTT.
Review CTT-developed documents including ES, protocol, amendments, and WSI (operational sections) , Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, data transfer plan, the Data Review & Surveillance Plan, recruitment and retention plan, committee chaters and / or other operational documents as requested to provide operational input (including on-time and high quality).
Ensure that clinical standards are followed for the study.
Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required.
5. Ensure proper collection and validation of data and documentation on a timely manner
Assure proper overview and communicate to teams of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures in collaboration with data manager, local CSU and relevant functions
6. Investigational Product (IP) Management.
Collaborate with the CSOM (Clinical Supply Operational Manager) to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process.
7. Collect, synthesize and report study information
Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
8. Preparation and oversight of study audits / inspections both internal and external
Ensure preparation and proper responses to audit / inspection reports & consolidation of findings and communicate important observations to CTT and / or DPE and Team Leader.
Develop and implement immediate action plan at global CSU / sites level if needed.
9. Provide oversight and preparation for 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, etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRS meetings to optimize monitoring efficiency & quality.
Knowledge and Skill Requirements
Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects.
Education / Training :
Bachelor's degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry
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