• Monitor and track patient enrolment and study progress• Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice as directed by the Sponsor/CRO.• Ensure patient enrolment within timeline and study progress smoothly• Identify, address, and resolve issues and problems as they might occur.• Coordinate day to day activities with CRA and CRO/Sponsor• Oversee and provide guidance to clinical research coordinators for the project specific duties

• Act as the Lead Clinical Data Manager for assigned studies or projects.• Performing routine data collection, source data verification.• Develop and maintain detailed project plans, and oversee the maintenance of the project Trial Master File.• Developed recruitment tools & strategies.• Provided inputs in data management plans, Safety plans, site agreements.• Maintains knowledge of therapeutic area, pharmaceutical regulations and the regulatory environment in order to ensure continued relevance and efficiency of development programs.• Planning and execution of investigator meeting (if required).• Participate in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor as well as Perform data review and query generation.• Participate in site feasibility, selection, site initiation, monitoring and close-out in accordance with applicable standard operating procedure (SOP)/study specific plan and Good Clinical practice (GCP).

Patient Recruitment and follow up, Drug Accountability, Submitting the CTA to OSP for review, Submitting Regulatory Documents to IRB & Sponsor, Maintaining Study &Patient Files. Documenting an Adverse event including: describing the event, Severity, Treatment, Resolution. Preparing for study closure and Archiving. Data Management & Queries Resolving.