• Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies • Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships • Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team. • Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget. • Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc. • Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs • Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues • Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development/revision, data collection, patient safety/AE management, document management, statistical analysis/final report writing, and study close out. • Management of small or medium-sized projects or regional leadership of complex multi-center clinical research projects • Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF • Perform any other tasks/duties as assigned by management