Clinical Project Manager (Investigator Sponsored Trials) - (Newton Center, MA)

SUMMARY: The Clinical Project Manager is responsible for the planning, implementation, execution, oversight and management of Investigator Sponsored Trials (ISTs) per the IST SOP(s). Identifies issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the budgetary and enrollment forecasting and tracking of each assigned IST, and develops and oversees study timelines. Tracks compliance with contractual and protocol reporting requirements and escalates issues as appropriate per the relevant business plan/SOP. RESPONSIBILITIES: Represents and leads the study team to develop, execute and manage global ISTs in accordance with IST goals, strategy, business plans and SOPs, in compliance Good Clinical Practices (GCP) and ICH Guidelines Assists with the planning and execution of applicable sponsor-investigators meetings, joint steering committee meetings, etc. Maintains accurate metrics for assigned ISTs