Project Data Manager

General Description: Project Data Management role is responsible for all aspects of the clinical trial datamanagement process from study start up through database lock and support of clinical studyreport (CSR) activities for assigned studies. This role is also accountable for quality ofdeliverables and resource efficiency of assigned studies. This role may be expected to leadmultiple clinical studies and/or oversee CRO/FSP vendors for multiple clinical studies. Essential Functions of the Job:

• Lead studies within a program
• Oversee data managers working on studies either in-house or CRO/FSP resources
• Serves as active member of Clinical Study Teams.
• Collaborates with other functions to develop timelines and ensure that clinical datamanagement deadlines
• are met.
• Defines external data transfer specifications and works with external vendors in supportof timelines and data
• related deliverables.
• Ensures process is in place to review and reconcile lab data with lab normal ranges
• Develops or oversees development of eCRF and edit check specifications as necessaryto support data
• collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, editchecks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial databasebuild and
• modifications.
• Develops or oversees development of study-specific eCRF Completion Guidelines andData Management
• Plans
• Creates and maintains data management documentation.
• Ensure data cleaning activities as specified in the Data Validation Specifications andData Management Plan.
• Works with coding group to ensure coding is applied to assigned clinical studies inconjunction with study
• timelines and deliverables.
• Defines listings in support of data management, clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers forstudies based on
• metrics data, audit reports, and input from other project team members.
• Will have the opportunity to drive all data review related activities. This will also includeidentifying and
• escalating potential data issues to LDM when issues arise.
• Trains other personnel on eCRFs and EDC, as needed.
• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs andother documents as
• required.
• Support management team with continued process improvement/innovation for thedepartment and
• participates in the development and maintenance of Standard Operating Procedures(SOPs) and Work
• Instructions related to data management activities.
• Will oversees data managers working on studies either in-house or CRO/FSP resourcesto ensure studying
• the support on the studies are sufficient.
• Collaborates with program lead and other functions to ensure program-consistent, highqualityand on-time
• data delivery.
• May mentor other junior Clinical Data Managers.
• Other duties as assigned.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.