Job
Description
Role Overview: The Manager Clinical Research will be responsible for independently managing assigned clinical studies, ensuring compliance with regulatory requirements, and overseeing site activities. The role involves coordinating key study documents, monitoring trial progress, managing budgets, and collaborating with stakeholders to ensure the successful execution of clinical trials. Key Responsibilities: Independently manage and oversee assigned clinical studies from initiation to completion. Coordinate the development and submission of key study documents, including protocols, Case Report Forms (CRFs), Clinical Study Reports (CSRs), ethics and regulatory submissions. Conduct Site Qualification Visits to identify appropriate sites for assigned projects. Perform Site Monitoring Visits for in-house projects and co-monitoring visits for outsourced projects. Prepare study budgets in consultation with the project manager, line manager, and business development team. Negotiate with investigators for site budgets and facilitate the execution of Clinical Trial Agreements (CTAs). Develop project and monitoring plans for clinical studies, ensuring adherence to timelines and milestones. Maintain and update trackers to evaluate study progress, identifying and communicating delays to the department head. Oversee study center activities, including initiation, monitoring, recruitment tracking, and close-out procedures. Lead and supervise Clinical Research Associates (CRAs), delegating tasks based on skill levels and enhancing team expertise. Ensure timely and accurate submission of documents for regulatory and ethics committee approvals. Review and assess vendor quotes, providing feedback and requesting revisions as necessary. Monitor trial expenditures and ensure alignment with budgetary targets, communicating variances to relevant stakeholders. Provide regular updates on in-house and outsourced study expenditures to the department head. Identify and resolve operational challenges in clinical trials, implementing process improvements where necessary. Act as the key operational interface in clinical trial management, ensuring smooth execution and compliance. Offer clinical research expertise to support other departments and functional teams. Contribute to the development and implementation of project-specific training programs for internal and external staff. Develop and execute orientation programs for new team members, providing ongoing training and professional development. Perform additional responsibilities as assigned related to clinical trial execution and management. Qualifications & Experience: Educational Background: B.Pharm / M.Pharm / PhD / BAMS / BHMS / MBBS 6 to 8 years of experience in clinical research, trial management, or related domains. Strong knowledge of regulatory requirements, clinical trial processes, and Good Clinical Practices (GCP). Experience in site monitoring, budget management, and vendor negotiations. Excellent leadership, communication, and problem-solving skills. Ability to manage multiple projects simultaneously and work collaboratively with cross-functional teams.
