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- Tasks: Lead data management for clinical trials, ensuring accuracy and compliance.
- Company: Join EPM Scientific, a leader in inclusive job opportunities for the over-50s.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Make a real impact in rare disease research while developing your skills.
- Qualifications: Bachelor's degree required; 3-5 years in clinical data management preferred.
- Other info: Experience with decentralized trials or RWE data is a plus.
The predicted salary is between 36000 - 60000 £ per year.
This job is brought to you by Jobs/Redefined, the UK\’s leading over-50s age inclusive jobs board.
EPM Scientific are seeking an experienced and detail-oriented Clinical Data Manager to join a growing clinical operations team. This role is critical in ensuring the integrity, accuracy, and quality of clinical trial data, with a particular focus on studies in rare and orphan diseases. You will work cross-functionally with clinical, biostatistics, regulatory, and external vendors to manage data across all phases of clinical development.
Responsibilities:
- Lead and manage end-to-end data management activities for assigned clinical trials, from study start-up through database lock.
- Develop and review data management plans (DMPs), case report forms (CRFs), edit check specifications, and data validation rules.
- Oversee data cleaning activities, including query generation and resolution, discrepancy management, and data reconciliation.
- Collaborate with CROs and external vendors to ensure timely and high-quality data deliverables.
- Ensure compliance with regulatory requirements (e.g., ICH-GCP, CDISC standards) and internal SOPs.
- Participate in protocol review, CRF design, and database build processes.
- Support audits and inspections by regulatory authorities.
- Provide input into the development of rare disease-specific data strategies, including patient-reported outcomes and real-world data integration.
- Contribute to continuous improvement initiatives within the data management function.
Qualifications and experience:
- Bachelor\’s degree in life sciences, health informatics, or a related field (Master\’s preferred).
- Minimum of 3-5 years of experience in clinical data management, with at least 1-2 years in rare disease or orphan drug trials.
- Strong understanding of clinical trial processes, data standards (CDISC, SDTM), and regulatory requirements.
- Proficiency with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault).
- Experience working with CROs and external vendors.
- Excellent organizational, communication, and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred skills:
- Experience with decentralized trials or real-world evidence (RWE) data.
- Familiarity with biomarker or genetic data integration.
- Knowledge of statistical programming languages (e.g., SAS, R) is a plus.
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Clinical Data Manager employer: EPM Scientific
Contact Detail:
EPM Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Data Manager
✨Tip Number 1
Familiarise yourself with the latest trends and regulations in clinical data management, especially those related to rare diseases. This knowledge will not only help you stand out during interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the clinical data management space, particularly those who have experience with rare disease trials. Attend industry conferences or webinars to make connections and learn from their experiences.
✨Tip Number 3
Gain hands-on experience with EDC systems like Medidata Rave or Oracle InForm if you haven't already. Consider taking online courses or certifications that focus on these platforms to enhance your technical skills.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios faced in clinical data management. Think about how you would handle data discrepancies or collaborate with CROs, as these are likely to come up during discussions.
We think you need these skills to ace Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management, especially any work related to rare diseases or orphan drug trials. Use specific examples to demonstrate your skills and achievements.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for clinical research and the importance of data integrity. Mention how your background aligns with the responsibilities listed in the job description.
Highlight Relevant Skills: In your application, emphasise your proficiency with EDC systems and your understanding of regulatory requirements. If you have experience with statistical programming languages or decentralized trials, make sure to include that as well.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects attention to detail, which is crucial for a Clinical Data Manager role.
How to prepare for a job interview at EPM Scientific
✨Know Your Data Management Fundamentals
Make sure you have a solid understanding of clinical data management principles, especially in relation to rare diseases. Be prepared to discuss your experience with data management plans, case report forms, and data validation rules.
✨Familiarise Yourself with Regulatory Standards
Brush up on ICH-GCP and CDISC standards, as well as any relevant internal SOPs. Demonstrating your knowledge of these regulations will show that you are serious about compliance and quality in clinical trials.
✨Highlight Your Collaborative Skills
Since the role involves working cross-functionally with various teams and external vendors, be ready to share examples of how you've successfully collaborated in the past. This could include managing relationships with CROs or resolving discrepancies in data.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities, such as how you would handle data discrepancies or manage a tight deadline. Think of specific examples from your previous roles that showcase your skills in these areas.
