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For Companies At a Glance
- Tasks: Lead complex clinical data reviews and collaborate with top scientists in the field.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Flexible home-based work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in oncology and cardiovascular research while advancing your career.
- Qualifications: 5+ years in data management and expertise in eCRF systems required.
- Other info: Dynamic role with a focus on innovation and continuous improvement in clinical data management.
The predicted salary is between 36000 - 60000 £ per year.
Looking for a data management expert, who has 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 closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study. Has prior experience of being involved and driving discussions with SRP/SRS and collaborates with the Data management team to establish, align, and confirm scientific clinical data review expectations for assigned trial(s). Extensive prior experience of 5+ years supporting studies within the therapeutic area Oncology or CV&M. Rave experience mandatory.
Deliverables
- Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Provides scientific data review support for more than one low to moderate complexity trial or one high complexity trial.
- The data management expert who, within the therapeutic area, is performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
- Tapping into technical and clinical expertise, closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when implementing the data management related activities for protocols, with focus on more complex indication and therapy related elements of the study.
- Reviews all necessary data flows, the Data Management Plans and performs continuous (complex) data review activities on the studies in the assigned program.
- Involved in study related activities from the protocol design stage onwards, providing input into the study specific and/or indication specific data collection tools.
- Reviews (complex) scientific study data, manages CDM and SRS/SRP related queries in EDC system.
- Involvement in other review activities (e.g., Coding, SAE reconciliation) is possible.
- Leads and/or attends meetings as appropriate.
- 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).
- With the trial customer, CRO and other functional partners in relation to CDM related activities:
- Reviews content and integration requirements for eCRF and other data collection tools.
- Establishes conventions and quality expectations for clinical data.
- Sets timelines and follows up regularly to ensure delivery of all Clinical Data Management milestones.
- Creates the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Reviews related clinical data management documents.
- Ensures compliance with regulatory guidelines and documentation requirements.
- Ensures real-time inspection readiness of all assigned deliverables for the trial; participates in Regulatory Agency inspection and Client internal audits as necessary.
- Plans and tracks applicable CDM deliverables.
- Ensures CDM deliverables are on time.
- Takes a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met.
- Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within clinical data management.
Education/Experience
- BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure.
- 5 years Data Management experience performing scientific (complex) clinical data review.
- Knowledge in medical terminology would be preferable.
- Must have experience in supporting the eCRF build.
- Rave knowledge and experience mandatory.
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
Network like a pro! Reach out to your connections in the industry, especially those who work in clinical data management. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Rave and the specific therapeutic areas mentioned in the job description. We want you to showcase your expertise and how it aligns with the role!
✨Tip Number 3
Don’t just wait for job alerts! Actively search for roles on our website and apply directly. This shows initiative and can set you apart from other candidates.
✨Tip Number 4
Follow up after interviews with a thank-you email. It’s a simple gesture that keeps you fresh in their minds and shows your enthusiasm for the position. We love seeing candidates who are genuinely interested!
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 is tailored to highlight your experience in clinical data management, especially in Oncology or CV&M. We want to see how your skills align with the job description, so don’t be shy about showcasing relevant projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention your collaboration with Study Responsible Physicians and Scientists, and how you’ve driven discussions in past roles.
Showcase Your Rave Experience: Since Rave experience is mandatory, make sure to highlight any specific projects where you’ve used this system. We want to know how you’ve leveraged Rave to manage complex clinical data effectively.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at IQVIA
✨Know Your Data Inside Out
Make sure you’re well-versed in the specifics of clinical data management, especially in oncology or cardiovascular studies. Brush up on your Rave experience and be ready to discuss how you've collaborated with Study Responsible Physicians and Scientists in past roles.
✨Prepare for Technical Questions
Expect questions that dive deep into your technical knowledge and experience. Be prepared to explain your approach to scientific data review and how you ensure compliance with regulatory guidelines. Use examples from your previous work to illustrate your expertise.
✨Showcase Your Leadership Skills
This role requires a leadership mindset, so think about times when you’ve led discussions or initiatives. Be ready to share how you’ve aligned expectations with team members and driven projects forward, particularly in complex trial settings.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about the specific challenges the team is currently facing or how they measure success in their data management processes. This shows your genuine interest and helps you gauge if the role is the right fit for you.
