Clinical Data Management Lead

hace 4 semanas

Ciudad de México, Ciudad de México Syneos Health, Inc. A tiempo completo
Sr. Project Data Manager Job Description

Company Overview

Syneos Health, Inc. is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Job Summary

We are seeking a skilled Clinical Data Management Lead to join our team. The successful candidate will be responsible for leading data management activities, ensuring launch, delivery, and completion of all data management activities and milestones according to contractual agreements and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.

Key Responsibilities

  1. Coordinate the work of the assigned data management/data operations team.
  2. Ensure launch, delivery, and completion of all data management activities and milestones according to contractual agreements and relevant SOPs, guidelines, and regulations.
  3. Provide project-specific training to internal and external audiences as required.
  4. Responsible for financial management of assigned projects/programs, including revenue recognition, changes in scope, and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed.
  5. Monitor and communicate project/program progress to the Sponsor and project team, including use of project status reports and tracking tools/metrics to enable in-stream data collection and query management.
  6. Support the management of resources on assigned projects/programs.
  7. Plan, manage, and request resources for assigned projects.
  8. Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
  9. Maintain documentation on an ongoing basis and ensure that all TMF filing is up to date.
  10. Participate in, and present at, internal, Sponsor, third-party, and investigator meetings.
  11. Plan for and create necessary documentation to support internal and external audits; participate in such audits.
  12. Train and mentor data management staff, act as a subject matter expert.
  13. Prepare input for, and participate in, proposal bid defense meetings.
  14. Maintain proficiency in data management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
  15. Perform other work-related duties as assigned. Minimal travel may be required (up to 25%).

Requirements

We are looking for a candidate with a BA/BS in the biological sciences or related disciplines in the natural science/healthcare field or registered nurse. In lieu of a degree, equivalent relevant work experience is accepted. The ideal candidate will have clinical data management experience or an equivalent combination of education and experience.

What We Offer

At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we consider transferable skills from previous roles.

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