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Looking for a data management expert with prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
Prior experience of collaborating with SRP, SRS, Data Management, and the study team when implementing data management activities for protocols, especially in complex indications and therapies.
Experience in driving discussions with SRP/SRS and working with Data Management to establish, align, and confirm scientific clinical data review expectations for trials.
Extensive experience (4+ years) supporting studies in Oncology or CV&M.
Mandatory Rave experience.
Deliverables:
* Adherence to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
* Provide scientific data review support for multiple trials of varying complexity.
* Perform scientific (complex) clinical data review in collaboration with SRP/SRS, reviewing data flows, Data Management Plans, and performing ongoing data review activities.
* Participate in study activities from protocol design, providing input into data collection tools.
* Review complex scientific study data, manage CDM and SRS/SRP queries in EDC systems, and participate in related activities like coding and SAE reconciliation.
* Lead or attend meetings as appropriate.
* Collaborate with SRP/SRS and GDM to establish and confirm scientific review expectations.
* Review content and requirements for eCRF and data collection tools, establish quality standards, set timelines, and ensure milestone delivery.
* Create and review the Integrated Review Plan, ensuring quality, scientific content, and regulatory compliance.
* Ensure inspection readiness and participate in audits as necessary.
* Track and ensure timely delivery of CDM milestones.
* Lead collaboration with SRS/SRP to meet trial needs and deliverables.
* Share lessons learned, best practices, and participate in process improvements.
Therapeutic areas: Oncology, Cardiovascular, and Immunology.
Education/Experience:
* BS/BA in Health Sciences or related field, or equivalent professional clinical experience.
* At least 4 years of Data Management experience, including clinical data review; knowledge of medical terminology is preferable.
* Experience supporting eCRF build.
* Mandatory Rave knowledge and experience.
This role is not eligible for UK visa sponsorship.
IQVIA is a leading global provider of clinical research services, insights, and healthcare intelligence. Learn more at https://jobs.iqvia.com
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