Clinical Data Manager (Medical Data Review) - Homebased (FSP)
Apply locations: Reading, Berkshire, United Kingdom
Time type: Full time
Posted on: Posted 2 Days Ago
Time left to apply: End Date: December 31, 2024 (30 days left to apply)
Job requisition id: R1452488
The Clinical Data Manager (CDM) will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
We are looking for a data management expert with prior experience in performing scientific (complex) clinical data review for at least 1+ years. The candidate should have experience closely collaborating with the SRP, SRS, Data Management functions, and the rest of the study team members when implementing data management related activities for protocols, focusing on more complex indication and therapy-related elements of the study. Extensive prior experience of 4+ years supporting studies within the therapeutic areas of Oncology or Cardiovascular & Metabolic (CV&M) is required.
Deliverables:
* Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
* Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
* Performs scientific (complex) clinical data review in close collaboration with the SRP and SRS, reviewing all necessary data flows and Data Management Plans.
* Involved in study-related activities from the protocol design stage onwards.
* Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system, and holds discussions with SRS/SRP.
* Takes a leadership role with SRP/SRS and collaborates with the GDM to establish, align, and confirm scientific clinical data review expectations for assigned trial(s).
* Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
* Ensures real-time inspection readiness of all assigned deliverables for the trial.
* Plans and tracks applicable CDM deliverables to ensure they are on time.
* Identifies and communicates lessons learned, best practices, and frequently asked questions at the trial level.
* Participates in process, system, and tool improvement initiatives within clinical data management.
Therapeutic Area: Oncology, Cardiovascular and Immunology
Education/Experience:
* BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
* 4 years of Data Management experience, preferably including clinical data review or significant experience with clinical data review.
* Knowledge in medical terminology is preferable.
* Collaboration with Clinical teams.
This role is not eligible for UK visa sponsorship.
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