The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget.
CTM levels reflect the experience, skill level, and capacity to manage larger and / or more complex studies, projects or programs.
This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham office 2-3 days per week).
Remote work is allowed, and the frequency is at the discretion of management.
Responsibilities
- 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 training
- Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
- Management of study drug distribution and accountability processes and documentation
- Oversight of study start-up, study management, data cleaning, and study closeout activities
- Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
- Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
- BA / BS degree in Health or Life Sciences required, advanced degree preferred
- A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
- Exceptional communication and interpersonal skills
- Positive team orientated attitude
- Must speak fluent English if it is their second language
- Advanced proficiency in Microsoft Office and Microsoft Project
- Reliable, self-motivated, team player
- Detail oriented with excellent organizational skills
- Ability to effectively manage multiple tasks and competing priorities
- Creative problem solver
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