At a Glance
- Tasks: Oversee clinical trial data quality and integrity 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.
- Other info: Dynamic role with potential for travel and excellent career advancement opportunities.
- 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; coding dictionary proficiency preferred.
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 in Edinburgh employer: Proclinical Staffing
Proclinical is an exceptional employer that prioritises the growth and development of its employees, offering a dynamic work culture that fosters collaboration and innovation in the life sciences sector. With a focus on oncology clinical trials, this role provides the unique opportunity to work remotely while occasionally engaging with teams in London or Egham, ensuring a flexible work-life balance. Employees benefit from comprehensive training, exposure to cutting-edge practices, and the chance to contribute to meaningful projects that impact patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Contract Clinical Data Manager in Edinburgh
✨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 asking for introductions. We all know someone who knows someone, so leverage that!
✨Tip Number 2
Prepare for those interviews! Research the company and the role thoroughly. Think about how your skills in EDC systems and data management align with their needs. We want you to shine, so practice common interview questions and have your own ready to go!
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, especially any projects related to oncology trials or data compliance. We love seeing real-life applications of your skills, so don’t hold back on sharing your successes!
✨Tip Number 4
Follow up after your 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. We’re all about making connections, so let’s keep that conversation going!
We think you need these skills to ace Contract Clinical Data Manager in Edinburgh
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 great fit for this role. We love seeing enthusiasm and a personal touch!
Showcase Relevant Experience:When filling out your application, be sure to showcase any relevant experience you have in clinical data programming and managing data integrity. We’re keen on seeing how you've tackled challenges in past roles, so don’t hold back!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s straightforward and ensures your application gets to the right people quickly. Plus, we’re here to help if you have any questions along the way!
How to prepare for a job interview at Proclinical Staffing
✨Know Your Data Inside Out
Make sure you brush up on your knowledge of clinical data management, especially in oncology. Be prepared to discuss your experience with EDC systems, eCRFs, and data validation processes. This will show that you’re not just familiar with the concepts but can also apply them effectively.
✨Familiarise Yourself with Regulatory Standards
Since compliance is key in this role, take some time to review ICH-GCP, 21 CFR Part 11, and CDISC-CDASH-SDTM standards. Being able to speak confidently about these regulations during your interview will demonstrate your commitment to maintaining high-quality data management practices.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like data discrepancies or managing queries. Think of examples from your past experiences where you successfully navigated similar challenges, as this will highlight your problem-solving skills and adaptability.
✨Showcase Your Communication Skills
As a Contract Clinical Data Manager, you'll need to liaise with various stakeholders. Be ready to discuss how you’ve effectively communicated complex data issues to non-technical team members or collaborated with CROs. This will illustrate your ability to work well in a team and ensure everyone is on the same page.
