Biomarker Operations Project Manager

1 week ago


BILLERICA MA, United States Parexel International Corporation Full time

We are looking for an experienced Biomarker Operations Project Manager to join our North America team

This is a remote position and will be project management and computer-based. In this role, you will support the operational set-up and management of biomarker specimens collected in global clinical trials.

Description of Role & Responsibilities:

  • Partner with cross-functional teams to ensure timely achievement of clinical and project related objectives
  • Responsible for the implementation of biomarker strategies, in accordance with all quality requirements and ethical & regulatory standards
  • Ensure biomarker-related information is accurately captured in areas including trial protocols, specimen logistics and workflows, systems, central lab and clinical site manuals, etc.
  • Serve as a subject matter expert for activities associated with biomarker specimens, including interactions with vendors (including labs and biorepositories) during protocol planning and trial execution
  • Accurately track biomarker-related activities and effectively communicate with project teams, including timelines, status, risks, and any known issues
  • Maintain effective communication and working relationships teams
  • Host planning meetings as needed for awareness and alignment

Skills and Experience:

  • Basic knowledge of clinical trial set-up and execution is required
  • Scientific, medical and/or safety writing and reporting is required (experience in at least one of these areas)
  • Experience in working with third party vendors preferred
  • Drug discovery and/or development experience is preferred
  • Understanding of basic clinical lab techniques is preferred
  • Knowledge of GCP, ICH guidelines, and regulatory requirements is preferred
  • Ability to collaborate effectively with a team
  • Must be self-motivated, and independent with self-awareness to know when to ask questions
  • Ability to manage complex projects under accelerated timelines. Formal project management experience is preferred.
  • Can independently prioritize work based on project needs and requirements
  • Well-organized and methodical approach to problem solving
  • Ability to understand needs of stakeholders
  • Strong issue identification and resolution skills
  • Able to learn quickly and be proficient in applicable tools and databases used to support the activities
  • Experience with MS Office Suite
  • Excellent communication skills, both written and oral

Educational Requirements: BA/BS with a science background required


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