Senior Project Data Manager – ClinSpark

• 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

• 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%)

• 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