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- Tasks: Oversee clinical trial data quality and compliance for oncology-focused studies.
- Company: Proclinical, a leading life sciences recruiter with a global reach.
- Benefits: Remote work flexibility, competitive pay, and opportunities for professional growth.
- Why this job: Make a real impact in oncology research while working with cutting-edge data management practices.
- Qualifications: Bachelor's degree in Life Sciences or related field; coding dictionary proficiency required.
- Other info: Dynamic role with potential for career advancement in a fast-paced environment.
The predicted salary is between 36000 - 60000 £ per year.
Proclinical is seeking a Contract Clinical Data Manager to support oncology-focused clinical trials. In this role, you will oversee the quality and integrity of clinical trial data, ensuring compliance with regulatory standards, internal SOPs, and industry best practices. This is a 6-month contract role, primarily remote, with occasional travel to London or Egham, Surrey, as needed.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Design, set up, and validate EDC systems, including defining and maintaining eCRFs, edit checks, and data management plans.
- Collaborate with CRO partners on database build, validation plans, and data transfer specifications.
- Perform ongoing data review, validation, and query management to ensure data accuracy and completeness.
- Reconcile data across multiple sources, including EDC, safety, labs, imaging, and pharmacovigilance, and support SAE reconciliation.
- Manage medical coding of adverse events, medical history, and medications using MedDRA and WHODrug.
- Ensure compliance with CDISC-CDASH-SDTM standards and internal guidelines.
- Act as the primary Data Management contact for studies, liaising with internal teams, CROs, and site staff.
- Support data preparation for DMCs, interim analyses, and database lock activities.
- Maintain audit-ready documentation and ensure adherence to ICH-GCP, 21 CFR Part 11, and company SOPs.
- Author and maintain Data Management-related SOPs.
Key Skills and Requirements:
- Bachelor\’s degree in Life Sciences, Computer Science, Data Science, or a related field (Master\’s preferred).
- Proficiency in coding dictionaries such as MedDRA and WHODrug, with familiarity in CDISC-CDASH-SDTM standards.
- Strong understanding of drug development phases (I-IV) and clinical trial processes.
- Experience in clinical data programming and the ability to review and evaluate clinical data.
- Excellent communication, problem-solving, and organizational skills.
- Agile thinker with a growth mindset and the ability to adapt to high-speed changes.
- Results-oriented with strong strategic thinking and planning capabilities.
- General data management skills, including maintaining GxP compliance and following standard operating procedures.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click \’Apply\’ or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you\’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.proclinical.com/privacy-policy
Contract Clinical Data Manager employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Contract Clinical Data Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical data management field. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EDC systems and CDISC standards. We recommend practising common interview questions related to data management and oncology trials. Confidence is key, so show them you know your stuff!
✨Tip Number 3
Tailor your approach! When applying through our website, make sure to highlight your relevant experience with MedDRA and WHODrug coding. Customising your application can really make you stand out from the crowd.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. Plus, it’s a great opportunity to reiterate why you’re the perfect fit for the position!
We think you need these skills to ace Contract Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Contract Clinical Data Manager role. Highlight your experience with EDC systems, data management, and compliance with regulatory standards. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about oncology-focused clinical trials and how your background makes you a perfect fit for this role. We love seeing genuine enthusiasm!
Showcase Relevant Experience: When filling out your application, be sure to showcase any relevant experience you have with MedDRA, WHODrug, and CDISC standards. We’re keen on candidates who can demonstrate their understanding of these key areas.
Apply Through Our Website: Don’t forget to apply through our website! It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it keeps everything nice and organised on our end!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Data Inside Out
Make sure you’re well-versed in the specifics of clinical data management, especially regarding EDC systems and coding dictionaries like MedDRA and WHODrug. Brush up on your knowledge of CDISC-CDASH-SDTM standards, as this will show your potential employer that you’re not just familiar with the basics but can also handle the complexities of the role.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experiences where you successfully tackled challenges in data management or compliance. Being able to articulate how you approached these situations will demonstrate your critical thinking and adaptability, which are key traits for a Contract Clinical Data Manager.
✨Communicate Clearly and Confidently
Since this role involves liaising with various teams and CROs, practice articulating your thoughts clearly. Use mock interviews to refine your communication style, ensuring you can convey complex information in an understandable way. This will help you stand out as a strong candidate who can effectively collaborate with others.
✨Be Ready for Regulatory Questions
Expect questions about ICH-GCP guidelines and 21 CFR Part 11 compliance. Familiarise yourself with these regulations and be prepared to discuss how you’ve ensured adherence in previous roles. This will highlight your commitment to maintaining high standards in clinical trials and data integrity.
