Job Description

JOB RESPONSIBILITIES: Prepare project plan as per the project timelines, budget and deliverables. Complete the assigned project in a Qualitative, cost-effective and time-bound manner. Develop the contract and budget for clinical trial projects. Conduct feasibility studies. Track timelines, milestones and budget requirements for assigned projects Coordinate for the required regulatory submission and approvals for the conduct of the study and CTRI registration. Allocate CTLs/CRAs to clinical trial projects. System enhancement in terms of developing appropriate study tools and tracking system Assist new CTLs/CRAs in identifying and developing investigators for assigned studies. Co-ordinate planning and conduct of clinical trial projects in liaison with CTLs/CRAs and other interdepartmental team members. Assist in selection of the sites in conjunction with sponsor and lambda and recommend site assignments. Provide protocol specific training to the CTLs/CRAs including therapeutic expertise, CRF conventions, study procedures and SOPs Supervise activities of the CTLs/CRAs including the scheduling of monitoring visits, other activities associated with the project (e.g. review of visit reports for completeness and accuracy, assisting monitors with site problems etc and time accountability for the project. Conduct quality control and co-monitoring visits with CTLs/CRAs to ensure quality and compliance with SOPs, GCP and project requirements. Assist and guide CTLs/CRAs in conducting pre study, initiation, interim and close out monitoring visits as required. Review and approve payments to the study site and vendors. Prepare reports and updates for sponsor. Ensure effective communication between stake holders and all project team members. Guide the software team in developing e-CRF. Identify and screen newer sites and PIs. Identify the improvement areas in project management team Create database of new PIs and sites. Any other responsibilities as assigned by the Management / HOD. Experience Required: 7 - 12 years