At a Glance
- 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 clinical trials while working with cutting-edge data management practices.
- Qualifications: Bachelor's degree in relevant field; experience in clinical data programming preferred.
- Other info: Dynamic role with potential for travel and excellent career advancement opportunities.
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, especially those who have experience with oncology trials. A friendly chat can lead to insider info about job openings or even referrals.
✨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 integrity and compliance to show you're the right fit for the role.
✨Tip Number 3
Don’t forget to showcase your problem-solving skills! During interviews, share specific examples of how you've tackled challenges in data management. This will help you stand out as a results-oriented candidate.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets noticed. Plus, if you have any questions, don’t hesitate to reach out to us for support.
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 these will likely come up during the interview.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experiences where you successfully tackled data discrepancies or compliance issues. Highlight your ability to think on your feet and adapt to changes, as this role requires agility in a fast-paced environment.
✨Communicate Clearly and Confidently
Since this role involves liaising with various teams and CROs, practice articulating your thoughts clearly. Use specific examples to demonstrate your communication skills and how you’ve effectively collaborated in previous roles.
✨Be Ready for Technical Questions
Expect technical questions related to data management processes and regulatory compliance. Review key concepts and be prepared to discuss how you ensure data integrity and quality in clinical trials, as this will show your expertise and readiness for the role.