Principal Clinical Data Manager, Mexico City - IQVIA Biotech POSITION TITLE: Principal Data Manager
REPORTS TO: Manager or Director level Data Management or Designee
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 projects Data 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 efficiency Represent DM as the functional lead at internal and Sponsor project team meetings Assumes ownership for DM project... deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor Provides and/or reviews staffing projections for DM activities for assigned program and/or projects Proposes process or system improvements for global implementation and participates in development and implementation Discusses roadblocks to Data Operations deliverables and potential strategies for overcoming with project team and/or Data Operations management and implements solutions Represents DM in regulatory and Sponsor audits for assigned study and/or program as well as general qualification audits by Sponsor Supervises daily team member activities Serves as a Data Management team leader Reviews team member activities and deliverables to ensure plans and processes are followed Assures 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 effectively Provides training of DM staff on project specific processes Oversees 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 management Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors Investigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews Assumes 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 services Coordinates 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 tools Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines Coordinates 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 requirements Coordinates 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 specifications Consolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisions Coordinates 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 services Performs testing for EDC systems as required per scope of services and standard operating procedures Verifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests Provides feedback to the other project team members and managers to improve the deliverables. Develops, Maintains and Archives DM Project Documentation including Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required Data review listing specifications Database Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications Database 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 phase Prepares project-specific slide presentation from DM template functional slides Participates in BDM preparation meetings including discussing overall DM strategy Presents DM slides at BDM and constructively participates in discussion Continuous Improvement Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates Serves as Data Operations mentor Creates 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 lock Provides open environment for question/issues about DM topics from within department and cross-functionally
KNOWLEDGE, SKILLS AND ABILITIES: Ability to lead technical and clinical team members Ability to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc) Ability to effectively communicate technical issues to non-DM team members and Sponsor Ability to maintain positive and open relations with internal, sponsor, and vendor team members Ability to facilitate team meetings and take meeting minutes Excellent knowledge of clinical trial concepts Proficiency with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT (preferred EDC systems are InForm and Rave) Ability to develop study-specific procedures Ability to maintain timelines using time management tools (@Task, MS Project, etc.) Excellent verbal, written and listening communications skills Ability to learn new things, teach others, and provide and accept constructive feedback Ability to create and adhere to detailed instructions Effective logical thinking ability regarding problem-solving skills Proficiency in computer applications and time management tools (e.g., MS Office)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Very little physical effort required to perform normal job duties (unless otherwise indicated) Occasional travel for bid defense meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses. Travel not anticipated to exceed 2-3 times per quarter.
MINIMUM RECRUITMENT STANDARDS: Bachelors degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification 10 years of experience in clinical trials within a similar function including: proven competence in managing delivery of multiple global projects / programs independently through full data management study life-cycle, including large and/or complex trials experience in handling complex customer negotiations and bid defense meetings Equivalent combination of education, training and experience
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Principal Clinical Data Manager, Mexico City - IQVIA Biotech IQVIA Mexico City