Clinical Trials Manager

4 weeks ago


Waltham, Massachusetts, United States Clinical Dynamix Full time
Clinical Trials Manager

The Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. This role requires a high level of experience, skill, and capacity to manage larger and/or more complex studies, projects, or programs.

  • Accountable for project-related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring 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 RFPs and vendor oversight plans.
  • Provides clinical leadership to CROs, other vendors, CRA teams, and CTAs.
  • Develops 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.
  • Plans, negotiates, and manages site budgets as well as facilitates site contracting process.
  • Develops and implements robust contingency and issue management plans to solve complex issues that impact study or program milestones.
  • May provide technical advice to team members.
  • Disseminates clinical program communications to all functional groups and leads program, study, and team meetings.
  • Interacts with clinical research investigators, Key Opinion Leaders, and sites.
  • Interacts 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-oriented 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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