Syneos Health

Senior Project Manager

Syneos Health

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
  • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
  • Lead project team to ensure quality, timelines and budget management.
  • Accountable for the financial performance of each project.
  • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
  • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
  • Accountable for all project deliverables for each project assigned.
  • Documentation and Reporting: Responsible for quality and completeness of TMF for assigned projects.
  • Accountable for maintenance of study information on a variety of databases and systems.
  • Responsible for study management components of inspection readiness for all aspects of the study conduct.
  • Oversight for development and implementation of project plans.
  • Plan, coordinate and present at internal and external meetings.
  • Prepare project management reports for clients and management.
  • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
  • Business Development: Develops strong relationships with current clients to generate new and/or add-on business for the future.
  • May participate in bid defense meetings where presented as potential project manager.
  • Management: May be required to line manage other project management team members and clinical monitoring staff.

Requirements

  • Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
  • Clinical research organization (CRO) and relevant therapeutic experience preferred.
  • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
  • Prior experience as Project Manager in a CRO environment is required.
  • Prior experience in Phase IV is a plus.
  • Strong organizational skills.
  • Strong ability to manage time and work independently.
  • Direct therapeutic area expertise.
  • Ability to embrace new technologies.
  • Excellent communication, presentation, interpersonal skills, both written and spoken.
  • Ability to travel as necessary (approximately 25%).