Job
Description
The Project Manager is responsible for the planning, execution, and completion of clinical trials, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs. This role involves coordinating with clinical trial sites, and ensuring that project timelines, budgets, and quality standards are met. The Project Manager serves as the central point of contact between sponsors, investigators, and internal stakeholders to ensure the successful delivery of clinical trials. Project Planning & Execution:- Create detailed project plans outlining study objectives, timelines, budgets, and key deliverables. Ensure that all aspects of the trial align with regulatory requirements and company goalsEstablish clear milestones for different phases of the clinical trial (site selection, patient recruitment, data collection, close-out, etc.)Ensure the trial follows Good Clinical Practice (GCP), ICH guidelines, and country-specific regulatory requirements. Oversee the preparation and submission of essential regulatory documentsIdentify potential risks (e.g., delays in patient recruitment, regulatory hurdles, protocol deviations) and develop proactive mitigation strategies to ensure the study remains on trackContinuously monitor trial progress against key performance indicators (KPIs) and take corrective actions when necessary. Team & Stakeholder Managem Lead and coordinate various internal and external stakeholders, including Clinical Research Associates (CRAs), regulatory specialists, data managers, medical writers, and site coordinatorsClearly define tasks and responsibilities for each team member to optimize efficiency and avoid bottlenecksAct as the primary point of contact for sponsors, Contract Research Organizations (CROs), regulatory agencies, investigators, and internal teams. Maintain transparent and proactive communication to align project goalsConduct performance reviews, resolve conflicts, and ensure that the team is well-equipped to handle project challengesOrganize periodic meetings to review progress, address roadblocks, and foster a culture of collaboration nt Site Management & Monitoring :- Evaluate and select appropriate clinical trial sites based on investigator experience, patient availability, infrastructure, and past performanceEnsure that investigators and site personnel receive adequate training on protocol adherence, data collection procedures, safety monitoring, and reporting requirementsOversee site visits conducted by CRAs, ensuring that study protocols are followed, patient safety is prioritized, and documentation is accurateAct as a point of escalation for site-related challenges, such as recruitment delays, adverse event reporting, or protocol deviationsEnsure proper documentation, compliance with close-out procedures, and knowledge transfer for final study analysis. Ensure that all necessary regulatory approvals, ethics committee submissions, and trial master files (TMF) are prepared and maintainedImplement Standard Operating Procedures (SOPs) and monitoring plans to ensure data integrity and compliancePrepare study sites and internal teams for audits by regulatory agencies (e.g., FDA, EMA, DCGI) and ensure timely resolution of any findingsEnsure that serious adverse events (SAEs) and adverse drug reactions (ADRs) are reported as per regulatory timelines and managed appropriately Show more Show less
