Senior/clinical Data Team Lead, Iqvia Biotech - Buenos Aires, Argentina - Novasyte
Descripción
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 startup through database closure and archival producing highquality databases for analysis and potential regulatory submissions
- Essential Functions:
- Manages DMrelated 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 DMspecific 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 reviewerreported 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 facetoface meetings, user group meetings or training courses. Travel not anticipated to exceed 23 times per quarter.
- Qualifications:
- Bachelor's degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification
- Advanced level of English
- Proven competence in managing delivery of multiple projects / programs independently through full data management study lifecycle
- Experience in handling bid defense meetings
- Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
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