Clinical Trial Manager

Senior Clinical Trial ManagerReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.Responsibilities (including, but not limited to):Accountable for project related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.Supports external vendor selection and management process and assists in the development of RFP's and vendor oversight plans.Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.Project leadership of the cross-functional study team, including external team members, CROs and vendors.Plan, negotiate, and manage site budgets as well as facilitate site contracting process.Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.May provide technical advice to team members.Disseminate clinical program communications to all functional groups and leads program, study and team meetings.Interact with clinical research investigators, Key Opinion Leaders and sites.Interact with Senior Management to report on progress of milestones.Oversight of study team and site trainingFacilitation of Quality processes and Quality Assurance interactions for assigned project(s)Management of study drug distribution and accountability processes and documentationOversight of study start-up, study management, data cleaning, and study closeout activitiesResponsible for final study files and documentation, including TMF, final TLFs, and final study data archivalProvides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.RequirementsBA/BS degree in Health or Life Sciences required, advanced degree preferredA minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager roleExceptional communication and interpersonal skillsPositive team orientated attitudeMust speak fluent English if it is their second languageAdvanced proficiency in Microsoft Office and Microsoft ProjectReliable, self-motivated, team playerDetail oriented with excellent organizational skillsAbility to effectively manage multiple tasks and competing priorities in a fast-paced environmentCreative problem solverStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)Ability to travel as neededThe salary range for this position is commensurate with experience