Clinical Data Management Project Lead
hace 1 mes
About Syneos Health
Syneos Health is a leading provider of biopharmaceutical solutions, committed to accelerating customer success. Our clinical development model puts the customer and patient at the forefront of everything we do.
We are constantly seeking ways to simplify and streamline our work, making Syneos Health easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
With 29,000 employees across 110 countries, we're dedicated to developing our people through career development and progression, supportive line management, technical training, and total rewards programs.
Job Responsibilities
- Act as Project Leader for stand-alone projects, including primary Sponsor contact for all contracted Data Management activities and deliverables.
- C 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.
- Monitor and communicate project/program progress to the Sponsor and project team.
- Support the management of resources on assigned projects/programs.
- Plan, manage, and request resources for assigned projects.
- Maintain documentation on an ongoing basis and ensure that all TMF filing is up to date.
- Participate in, and present at internal, Sponsor, third-party, and investigator meetings.
- Prepare input for, and participate in proposal bid defense meetings.
Requirements
- Bachelor's degree in 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.
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
Estimated Salary: $85,000-$115,000 per year
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