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- Tasks: Manage complex clinical data reviews and collaborate with study teams to ensure data integrity.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Enjoy remote work flexibility and opportunities for professional growth.
- Why this job: Be part of impactful research that improves patient outcomes worldwide.
- Qualifications: 4+ years in Data Management, especially in Oncology or Cardiovascular & Metabolism, with Rave system expertise.
- 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 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:
- Adherence to applicable SOPs, Work Instructions, policies, local regulations, ICH-GCP, etc.
- Provide scientific data review support for multiple trials of varying complexity.
- Perform scientific (complex) clinical data reviews in collaboration with SRP and SRS, focusing on complex indication and therapy-related elements.
- Review data flows, Data Management Plans, and perform continuous data review activities.
- Participate from the protocol design stage, providing input on data collection tools.
- Review scientific study data, manage queries in EDC systems, and participate in review activities like coding and SAE reconciliation.
- Lead or attend meetings as appropriate.
- Collaborate with SRP/SRS and GDM to establish review expectations.
- Review content and integration requirements for eCRF and data collection tools.
- Establish conventions and quality expectations for clinical data.
- Set timelines and ensure delivery of CDM milestones.
- Create the Integrated Review Plan and ensure compliance with regulatory standards.
- Ensure readiness for inspections and participate in audits.
- Track CDM deliverables and ensure timely completion.
- 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.
Clinical Data Manager - homebased (FSP) employer: Nanosep AB
Contact Detail:
Nanosep AB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Data Manager - homebased (FSP)
✨Tip Number 1
Network with professionals in the clinical data management field, especially those who have experience with Rave systems. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in Oncology and Cardiovascular & Metabolism.
✨Tip Number 2
Familiarise yourself with the specific protocols and data management activities related to complex indications and therapies. This will not only enhance your understanding but also allow you to speak confidently about your relevant experience during interviews.
✨Tip Number 3
Prepare to discuss your previous collaborations with Study Responsible Physicians and Scientists. Highlight specific examples where you contributed to establishing review expectations or improving data management processes, as this will demonstrate your ability to work effectively within a team.
✨Tip Number 4
Stay updated on regulatory standards and best practices in clinical data management. Being knowledgeable about ICH-GCP guidelines and local regulations will show your commitment to compliance and quality in your work.
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 & Metabolism therapeutic areas. Emphasise your familiarity with Rave systems and any specific projects where you collaborated with Study Responsible Physicians and Scientists.
Craft a Strong Cover Letter: In your cover letter, explain why you're the perfect fit for this role. Discuss your experience in performing complex scientific clinical data reviews and how you've successfully collaborated with study teams to meet data management expectations.
Showcase Relevant Skills: Highlight your skills in data review, query management, and your understanding of regulatory standards. Mention any experience you have with eCRF builds and your ability to establish quality expectations for clinical data.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no typos or grammatical errors, as attention to detail is crucial in clinical data management roles.
How to prepare for a job interview at Nanosep AB
✨Know Your Data Management Basics
Make sure you have a solid understanding of data management principles, especially in the context of clinical trials. Brush up on your knowledge of Rave systems and be prepared to discuss how you've used them in past roles.
✨Showcase Your Collaborative Skills
Since this role involves working closely with Study Responsible Physicians and Scientists, be ready to share examples of how you've successfully collaborated with different teams. Highlight any specific instances where your input influenced data collection tools or review processes.
✨Prepare for Technical Questions
Expect questions that dive deep into your experience with complex scientific data reviews. Be prepared to discuss specific challenges you've faced in Oncology or Cardiovascular & Metabolism studies and how you overcame them.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with ICH-GCP guidelines and other relevant regulations. Be ready to explain how you've ensured compliance in previous roles, particularly in relation to SOPs and audit readiness.
