Job title: R&D; Clinical Trial Support Manager
- Location: Hyderabad
About the job
Clinical Trial Support Manager (CTSM) supports the clinical study leader in execution and delivery of clinical studies. The CTSM is responsible for the activities that will be delegated to her/him including the preparation of study related plans and materials, appropriate escalation of issues, identification of study risks and contingency planning, monitoring of the study plan, and support of the clinical study leader in the overall management of budget tracking and invoice approval. In some cases, there might be a need to support some vendor activities. The CTSM acts with critical thinking and problem-solving mindset and executes her/his tasks with integrity and suitable for regulatory review.The study leader will have oversight of the CTSM activities.
Main responsibilities include:
Ensure proper study documentation/availability, Develop / contribute with study team members all required study documents as per SOP including but not limited to the Study Risk Management Plan (SRMP),
Monitoring Plan (MP), Study Communication Plan, Training Material, recruitment and retention plan, Who’s who and study operational materials including memos, study newsletters
Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF (Case Report Form) and completion guidelines, Centralized Monitoring Plan, committee charters and/or other operational documents as requested to provide operational input.Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required.
Develop and manage the study budget under supervision:
Support the study leader in preparing the overall study budget and tracking expenditures against it.
Supporting quarterly forecasts and following expenses / accruals, identify and evaluate complementary needs.
Perform final budget reconciliation with vendors at study e