Clinical Data Manager - homebased (FSP)

Clinical Data Manager - Homebased (FSP)

Apply locations: Reading, Berkshire, United Kingdom; Bloemfontein, South Africa; Dublin, Ireland; Centurion, South Africa; London, United Kingdom

Time type: Full time

Posted on: Posted 2 Days Ago

Time left to apply: End Date: January 31, 2025 (30+ days left to apply)

Job requisition id: R1452488

The CDM will perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

Looking out for a data management expert who has prior experience in performing scientific (complex) clinical data review in close collaboration with the SRP and SRS for at least 1+ years. The candidate should have experience 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 area of Oncology or CV&M is also required.

Deliverables:

1. Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
2. Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
3. Performs scientific (complex) clinical data review in collaboration with the SRP and SRS, focusing on complex indication and therapy-related elements of the study.
4. Reviews all necessary data flows, Data Management Plans, and performs continuous (complex) data review activities on the studies in the assigned program.
5. Involved in study-related activities from the protocol design stage onwards, providing input into study-specific and/or indication-specific data collection tools.
6. Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in eDC system, and holds discussions with SRS/SRP. Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
7. 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).
8. Collaborates with trial customers, CRO, and other functional partners regarding CDM related activities.
9. Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
10. Ensures real-time inspection readiness of all assigned deliverables for the trial; participates in Regulatory Agency inspections and Client internal audits as necessary.
11. Plans and tracks applicable CDM deliverables, ensuring they are on time.
12. Identifies and communicates lessons learned, best practices, and frequently asked questions at the trial level.
13. Participates in process, system, and tool improvement initiatives within clinical data management.

Therapeutic Area: Oncology, Cardiovascular, and Immunology

Education/Experience:

1. BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
2. 4 years Data management experience, preferably including clinical data review or significant experience with clinical data review. Knowledge in medical terminology would be preferable.
3. Collaboration with Clinical teams.

This role is not eligible for UK visa sponsorship.

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