Senior Clinical Data Team Lead, IQVIA Biotech

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)