Senior Project Data Manager – ClinSpark
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Job Description
Senior Project Data Manager leading clinical data management projects for Syneos Health, a life sciences services organization. Coordinating teams, sponsors, systems, workflows, compliance, and delivery.
Responsibilities:
- Manage all data management services for assigned projects
- Act as Project Leader and primary Sponsor contact for contracted Data Management activities and deliverables on stand-alone projects
- Act as Functional Lead for Data Management and primary internal liaison on full-service projects
- Coordinate assigned Data Management/Data Operations teams
- Ensure launch, delivery, and completion of Data Management activities and milestones according to contracts, SOPs, guidelines, and regulations
- Provide project-specific training to internal and external audiences
- Manage project finances, revenue recognition, scope changes, and internal project review participation
- Monitor and communicate project/program progress using status reports, tracking tools, and metrics
- Support and request resource management for assigned projects/programs
- Develop and maintain project plans, specifications, and documentation
- Maintain ongoing documentation and ensure TMF filing is up to date
- Participate in and present at internal, Sponsor, third-party, and investigator meetings
- Create documentation for and participate in internal and external audits
- Train and mentor data management staff and act as a subject matter expert
- Prepare input for and participate in proposal bid defense meetings
- Maintain proficiency in Data Management systems and processes through regular training
- Attend or represent the company at professional meetings/conferences as needed
- Perform other related duties as assigned
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 of EDC programming and Rave web service to integrate data
- Knowledge of CDISC, including CDASH, SDTM, ODM-XML, and Pinacle 21
- Experience working with eSource data directly or eSource data capture systems
- 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, particularly requirements applicable to Clinical Data Management
- Contract Research Organization (CRO) experience preferred
- Minimal travel may be required (up to 25%)
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, under the Americans with Disabilities Act
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