IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment.
The sector we are in is cutting edge for therapies with un-met medical needOffering : 1000s online personal training coursesCareer development and supportCompetitive SalariesAnnual Bonus BASIC FUNCTIONS :
Principal Data Manager position is to manage all data management (DM) activities for more complex, larger projects and / or program of studies from start-up through database closure and archival, producing high quality databases for analysis and potential regulatory submissions.
The Principal Data Manager also serves in a leadership role within Data Operations to train and mentor other staff in data management functions.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES :
Data Operations Oversight of the program and / or projectsData Operations lead for internal / client team meetings and communication collaborating with the project team on overall Data Operations strategy for the program and / or projects assuring overall quality and efficiencyRepresent DM as the functional lead at internal and Sponsor project team meetingsAssumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projectionsProvides proactive, timely communication of project status, data trends and issue resolution with internal team and SponsorDevelops, generates and analyzes project progress and / or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and SponsorProvides and / or reviews staffing projections for DM activities for assigned program and / or projectsProposes process or system improvements for global implementation and participates in development and implementationDiscusses roadblocks to Data Operations deliverables and potential strategies for overcoming with project team and / or Data Operations management and implements solutionsRepresents DM in regulatory and Sponsor audits for assigned study and / or program as well as general qualification audits by Sponsor
Supervises daily team member activitiesServes as a Data Management team leaderReviews team member activities and deliverables to ensure plans and processes are followedAssures project activities are performed within budget and according to expected timelines and meet high quality standards.
Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectivelyProvides training of DM staff on project specific processesOversees the DM project and / or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to : Discrepancy managementData Reconciliation (e.
g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and / or 3rd party vendorsInvestigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviewsAssumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements
Oversees System Development and Modifications : Develops and implements DM strategy on the project / program based on scope of servicesCoordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing and implementation of all data capture toolsCoordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelinesCoordinates with the Technical Design and Clinical Programming team and / or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirementsCoordinates with the EDC programmers and / or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work.
Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specificationsConsolidates reviewer comments from internal team / sponsor and collaborates with the project and Clinical Programming team, as required, for revisionsCoordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and / or projects
Oversees System and Data Listing Testing Activities : Coordinates testing activities for the EDC technologies per scope of servicesPerforms testing for EDC systems as required per scope of services and standard operating proceduresVerifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requestsProvides feedback to the other project team members and managers to improve the deliverables.
Develops, Maintains and Archives DM Project Documentation includingData Management Plan, Data Review Plan, CRF Completion Guidelines.
and other study-specific plans as requiredData review listing specificationsDatabase Design Documents, Edit Specifications, Reconciliation guidelines, and Report specificationsDatabase lock documentation
Represents Data Management in Proposal Process and at Bid Defense Meetings (BDM)Participates in the development of DM strategies during the bid and award phasePrepares project-specific slide presentation from DM template functional slidesParticipates in BDM preparation meetings including discussing overall DM strategyPresents DM slides at BDM and constructively participates in discussion
Continuous ImprovementRecommends and assists in the development of standards and / or improvements to existing standards including processes, CRFs, data listing reports and document templatesServes as Data Operations mentorCreates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lockProvides open environment for question / issues about DM topics from within department and cross-functionally