Abhijith Madhusudhanan

• Coordinate multiple batch production, inventory activities, including ordering and requisitions.
• Support quality assurance team for audits and internal reviews.
• Complete batch records, logbooks, and other quality records.
• Operate various pieces of production equipment

• Provided all administrative support in system access management for project, program, and partnership.
• Improved data accuracy by implementing stringent quality control measures for data management.
• Initiated and maintained core project documents and study documents in TMF throughout the project.
• Scheduled and coordinated meeting with study leads, Investigators, CRAs and sponsors for the smooth deliverables of the project. Prepared and distributed meeting minute, agendas, action items and followed up with study team for the closure of the action items.
• Ensured the trial teams are aware of the most recent developments or updates in documentation management in TMF
• Identified and addressed potential study risks and escalated the project risks and outcomes to the senior project manager for preventive action (CAPA).
• Coordinated with system set up analyst to ensure that systems (IH, Medidata, PMED, Vault e-TMF) and system interfaces are functioning and are ready for use for project teams.
• Performed review for SOP, PMP, RMP, PSSMP, study protocols and Teamlist in Veeva vault (TMF) on timely manner.
• Collaborated with Project Leader, Clinical Operational Lead, Patient Recruitment, Statistical Programmer, CRA, CRC, Data Management Lead, Quality Affairs, Regulatory Affairs and Safety to ensure that project deliverables are completed on time.
• Extracted internal and external system reports from Vault e-TMF and provided the required information to the project team.
• Coordinated with project leads to ensure documents are achieved and final reports are handed over to the sponsor.
• Supported in the TMF's close-out process and overseeing the planning, monitoring, and recording of all trial-level records in accordance with internal and external guidelines.

Compliance with Parexel Standards

• Completed timesheets accurately as required.
• Updated CV as required.
• Finished required training curriculum.

• Approval of online prescriptions
• Maintained up-to-date knowledge on emerging pharmaceutical trends by attending conferences and completing continuing education courses.
• Educated patients about possible drug interactions and gave special administration instructions.