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- Tasks: Manage and review complex clinical data while collaborating with study teams.
- Company: IQVIA is a top global provider of clinical research services and healthcare insights.
- Benefits: Enjoy the flexibility of a home-based role with opportunities for professional growth.
- Why this job: Join a dynamic team making an impact in Oncology and Cardiovascular research.
- Qualifications: 4+ years in Data Management with mandatory Rave experience; health sciences degree preferred.
- Other info: This role is not eligible for UK visa sponsorship.
The predicted salary is between 36000 - 60000 £ per year.
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.
Clinical Data Manager - homebased (FSP) employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Data Manager - homebased (FSP)
✨Tip Number 1
Make sure to highlight your experience in Oncology or Cardiovascular studies during networking events or conversations. This will help you connect with professionals who can refer you to opportunities at IQVIA.
✨Tip Number 2
Engage with online forums and groups related to clinical data management, especially those focusing on Rave systems. This can provide insights into the latest trends and may lead to job referrals.
✨Tip Number 3
Consider reaching out to current or former employees of IQVIA on LinkedIn. Ask them about their experiences and any tips they might have for applying to the Clinical Data Manager role.
✨Tip Number 4
Stay updated on the latest developments in clinical data management and regulatory requirements. This knowledge can be a great conversation starter in interviews and shows your commitment to the field.
We think you need these skills to ace Clinical Data Manager - homebased (FSP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical data management, especially your work with oncology or cardiovascular studies. Emphasise your Rave experience and any collaboration with Study Responsible Physicians and Scientists.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the requirements of the Clinical Data Manager role. Mention your experience in scientific data review and how you have successfully collaborated with study teams in the past.
Showcase Relevant Skills: In your application, clearly outline your skills related to data management activities, such as your ability to establish quality standards and ensure compliance with regulatory requirements. Use specific examples to demonstrate your expertise.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A well-presented application reflects your attention to detail, which is crucial in clinical data management.
How to prepare for a job interview at IQVIA
✨Showcase Your Data Management Expertise
Be prepared to discuss your previous experience in clinical data management, especially in Oncology or Cardiovascular studies. Highlight specific projects where you collaborated with Study Responsible Physicians and Scientists, detailing your role and contributions.
✨Demonstrate Knowledge of Rave
Since Rave experience is mandatory, ensure you can speak confidently about your familiarity with this system. Prepare examples of how you've used Rave in past roles, particularly in managing eCRF builds and data review processes.
✨Understand the Regulatory Landscape
Familiarise yourself with ICH-GCP guidelines and local regulatory requirements relevant to clinical trials. Be ready to discuss how you have ensured compliance in your previous roles and how you would approach this in the new position.
✨Prepare for Collaborative Discussions
Expect to engage in discussions about scientific data review expectations. Think of examples where you successfully led or participated in meetings with SRP/SRS and how you navigated differing opinions to reach a consensus.
