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Sr. Clinical Trial Manager

Boston, MA 02110

Posted: 06/09/2025 Employment Type: Direct Hire Industry: Medical Affairs Job Number: 12189 Pay Rate: $160k - $180k Remote Friendly: Work from home flexibility

Job Description

Our client is a biopharmaceutical company working on therapies for immunological diseases.

Overview:
  • The Senior Clinical Trial Manager is responsible for the management of clinical studies across phases including actively participating in a variety of activities to support and facilitate the efficient conduct of patient trials in our clinical research programs.
  • Reporting to the VP, Head of Clinical Operations, you will be responsible for supporting the critical day-to-day clinical study activities, including development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filings.

Responsibilities:
  • In partnership with Clinical Trial Associate, study teams, and Clinical Research Organizations (CROs), lead and support clinical study activities as defined by the clinical trial operating model.
  • Managing all aspects of study progress from start-up to close-out activities, assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.
  • Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
  • Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, database set-up, regulatory document filing.
  • Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals). Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
  • Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
  • Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution.

Job Requirements

Qualifications:
  • Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field.
  • 5 or more years clinical research experience in industry settings with at least 3 years managing clinical trials.
  • Experience working on phase III, later stage large global studies with multiple vendors, managing submission timelines and associated processes.
  • Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required.
  • Solid project and vendor management, analytical and problem-solving skills.
  • Knowledge of GCP/ICH Guidelines for clinical studies.
  • Ability to work independently and take initiative in a fast-paced work environment.
  • Excellent verbal and written communication skills.
  • Competent computer skills including Microsoft Office.
  • Familiarity with clinical systems.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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