Senior/clinical Data Team Lead, Iqvia Biotech

hace 4 meses

Buenos Aires, Argentina Novasyte A tiempo completo

Join our team as a Senior Data Team Lead, IQVIA Biotech
- Senior Data Team Lead position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.- Essential Functions:
- Manages DM-related aspects of the program and/or project
- Collaborates with the project team on overall data management 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
- 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
- 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
- Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
- Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
- Reviews and provides DM staffing projections for program and/or projects
- Presents EDC and/or CRF completion at Investigator Meetings
- Participates in regulatory and Sponsor audits for program and/or projects
- Oversees daily team member activities
- Serves as a Data Management team leader
- 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
- 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
- Oversees System Development and Modifications
- Oversees System and Data Listing Testing Activities.
- Develops, Maintains and Archives DM Project Documentation including.- Represents Data Management at Bid Defense Meetings (BDM)
- Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates- 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.
- Qualifications:
- Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification
- +5 years of experience in clinical trials within a similar function.
- Advanced level of English
- Proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycle
- Experience in handling bid defense meetings
- Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
- #LI-RemoteIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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