Senior Project Data Manager (ClinSpark)

Syneos Health is hiring a Senior Project Data Manager (ClinSpark) to lead data management services for assigned clinical research projects. The role oversees project delivery, sponsor communication, team coordination, resources, financial management, and compliance with contractual and regulatory requirements.

Responsibilities:

• On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
• Coordinate the work of the assigned Data Management/Data Operations team
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Provides 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
• Monitors and communicates 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
• Supports 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
• Trains and mentors data management staff, acts as a subject matter expert
• 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%)

Requirements:

• 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
• Technical knowledge like EDC programming and Rave web service to integrate data
• Knowledge about CDISC (e.g. CDASH, SDTM, ODM-XML, Pinacle 21)
• Experience working with eSource data directly or eSource data capture system
• Experience developing new processes and tools
• Experience designing and implementing data workflows
• Ability to evaluate, improve, and optimize operational processes
• Experience managing data mapping activities
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• 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
• 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 for clinical studies, in particular requirements applicable to Clinical Data Management
• Contract Research Organization (CRO) experience preferred