Pratap Misal

Project Manager @Reliance Life Sciences Pvt. Ltd

Navi Mumbai, IN

Proactively manage project level operational aspects of Clinical Trial including management of trial timeline, budget, resources and vendors.Plans, implements and evaluates all clinical trial activities provided by the project team assigned to a project, as well as all associated administrative activities.Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.Participating in the preparation, review, updating, and training of SOPs.Designs, establishes and maintains a project work breakdown structure and plan to effectively accomplish the project’s goals and objectives.Reviews, establishes, and maintains project implementation standards, ensuring that all applicable regulations and guidelines are met.Establishes and implements short- and long-range project team quality and timeline goals, objectives and project-specific procedures; monitors and evaluates operational effectiveness, risks, and effects changes required for improvement.Develops and manages budgets for the project and performs periodic cost analysesPerforms miscellaneous job-related duties as assigned by supervisorFor specific complex trials, may perform training, selection, initiation, monitoring and co-monitoring activities for investigator sitesHandling activities related to computer systems (e.g. QAMS, eDMS, SAP, EDC etc.)

Bharati Vidyapeeth

B.Sc.