Description
Syneos Health is seeking a Senior Project Data Manager (ClinSpark) to join their Clinical Solutions team. The successful candidate will be responsible for project management of all data management services for assigned projects, ensuring that contracted Data Management activities are carried out in accordance with the executed contract and Sponsor's expectations.
Core Responsibilities:
- Act as Project Leader for standalone projects, 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
- Manage financial aspects of assigned projects/programs, including revenue recognition and participation in internal project review meetings
- Monitor and communicate project/program progress to the Sponsor and project team
- Support resource management on assigned projects/programs
- Plan, manage, and request resources for assigned projects
- Develop and maintain project plans, specifications, and documentation in line with SOP requirements
- Maintain documentation and ensure that all TMF filing is up to date
- Participate in internal, Sponsor, third-party, and investigator meetings
- Plan for and create necessary documentation to support internal and external audits
- Train and mentor data management staff, acting as a subject matter expert
- Prepare input for proposal bid defense meetings
- Maintain proficiency in Data Management systems and processes through regular training
Qualifications:
- BA/BS in biological sciences or related disciplines in the natural science/health care field, or Registered Nurse
- Clinical data management experience or an equivalent combination of education and experience
- Experience in Clinical Data Management practices and relational database management software systems
- Technical knowledge in EDC programming, Rave web service, CDISC (e.g., CDASH, SDTM, ODM-XML, Pinacle 21), and eSource data capture systems
- Experience developing new processes and tools, designing and implementing data workflows, and managing data mapping activities
- 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
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
- Effective oral and written communication skills
- Strong presentation skills
- Good organizational, planning, and time management skills with the ability to multitask under tight deadlines
Benefits: Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.