Senior Project Data Manager

hace 4 semanas

Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo
Job Title: Senior Project Data Manager

At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

Job Responsibilities:
  • Act as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables.
  • Coordinate the work of the assigned Data Management/Data Operations team.
  • Ensure launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
  • Provide project specific training to internal and external audiences as required.
  • 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.
  • 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.
  • Support the management of resources on assigned projects/programs.
  • Plan, manages and requests resources for assigned projects.
  • Develop and maintain project plans, specifications and documentation in line with SOP requirements.
  • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date.
  • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
  • Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
  • Prepares input for, and participates in proposal bid defense meetings.
  • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
  • Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
Qualifications:
  • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.
  • Clinical data management experience or an equivalent combination of education and experience.
  • Experience in Clinical Data Management practices and relational database management software systems.
  • Strong project management skills and knowledge of project management methodologies.
  • Demonstrated staff leadership skills.
  • Contract Research Organization (CRO) experience preferred.
  • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices.
  • Effective oral and written communication skills.
  • Strong presentation skills.
  • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
  • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
  • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
  • Knowledge of ICH/GCP regulatory requirements.

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