Clinical Data Manager - homebased (FSP)

Nanosep AB; London; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a data management expert to join their dynamic team in London. This role involves performing complex scientific clinical data reviews and collaborating closely with Study Responsible Physicians and Scientists. The ideal candidate will have over four years of experience in oncology or cardiovascular studies, along with mandatory knowledge of Rave systems. If you're passionate about improving patient outcomes and thrive in a collaborative environment, this opportunity is perfect for you. Join a leading global provider of clinical research services and make a significant impact in the healthcare sector.

Qualifications

• 4+ years of experience in Data Management and clinical data review.
• Mandatory knowledge of Rave systems and medical terminology.

Responsibilities

• Perform complex scientific clinical data reviews in collaboration with SRP and SRS.
• Ensure compliance with regulatory standards and manage CDM deliverables.

Skills

Clinical Data Review

Data Management

Oncology Studies

Cardiovascular & Metabolism

Collaboration with SRP/SRS

Education

BS/BA in Health Sciences

Equivalent Professional Clinical Experience

Tools

Rave Systems

Job description

Looking for a data management expert with prior experience in performing complex scientific clinical data reviews in close collaboration with Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).

The candidate should have experience working closely with SRP, SRS, Data Management, and other study team members to implement data management activities, especially for protocols involving complex indications and therapies.

Must have supported discussions with SRP/SRS and collaborated with the Data Management team to establish and confirm scientific clinical data review expectations for assigned trials.

Extensive experience (4+ years) supporting studies in Oncology or Cardiovascular & Metabolism (CV&M) therapeutic areas is required.

Mandatory experience with Rave systems.

Deliverables:

1. Adherence to applicable SOPs, Work Instructions, policies, local regulations, ICH-GCP, etc.
2. Provide scientific data review support for multiple trials of varying complexity.
3. Perform scientific (complex) clinical data reviews in collaboration with SRP and SRS, focusing on complex indication and therapy-related elements.
4. Review data flows, Data Management Plans, and perform continuous data review activities.
5. Participate from the protocol design stage, providing input on data collection tools.
6. Review scientific study data, manage queries in EDC systems, and participate in review activities like coding and SAE reconciliation.
7. Lead or attend meetings as appropriate.
8. Collaborate with SRP/SRS and GDM to establish review expectations.
9. Review content and integration requirements for eCRF and data collection tools.
10. Establish conventions and quality expectations for clinical data.
11. Set timelines and ensure delivery of CDM milestones.
12. Create the Integrated Review Plan and ensure compliance with regulatory standards.
13. Ensure readiness for inspections and participate in audits.
14. Track CDM deliverables and ensure timely completion.
15. Identify lessons learned and participate in process improvements.

Education and 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 and knowledge of medical terminology.
• Experience supporting eCRF build.
• Mandatory Rave system knowledge and experience.

This role is not eligible for UK visa sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We aim to accelerate the development and commercialization of medical treatments to improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.