At a Glance
- Tasks: Manage and review clinical trial data for accuracy and compliance.
- Company: Join a leading organisation in clinical research with a focus on innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with strong emphasis on training and development.
- Why this job: Make a real difference in healthcare by ensuring data integrity in clinical trials.
- Qualifications: Bachelor’s degree in Life Sciences and 2 years of clinical data management experience.
The predicted salary is between 40000 - 50000 € per year.
The Clinical Data Manager II will provide comprehensive data management support for assigned clinical studies. The CDM will be responsible for performing ongoing data review to ensure accuracy, completeness, and consistency of clinical trial data in accordance with the study protocol and data management plan. The CDM will have a minimum of two years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave.
Responsibilities
- Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency.
- Identify, investigate, and resolve data discrepancies through query management.
- Conduct manual and system-driven data reviews in accordance with study protocols and DMPs.
- Collaborate with cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities.
- Participate in database lock activities and ensure data readiness for interim and final analyses.
- Maintain study documentation in compliance with regulatory requirements and internal SOPs.
- Manage and maintain user access within clinical data management systems (e.g., Medidata Rave).
- Process access requests, modifications, and terminations in accordance with established procedures.
- Ensure appropriate role-based access and system permissions are assigned.
- Maintain audit-ready documentation related to user access activities.
- Support periodic access reviews and compliance checks.
- Assist with system user training and troubleshooting as needed.
Qualifications
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
- Minimum of 2 years of clinical data management experience.
- Demonstrated hands-on data review experience in clinical trials.
- Proficiency in Medidata Rave (build knowledge a plus, but not required).
- Cloud Administration module experience is preferred.
- Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines).
- Experience with query management and discrepancy resolution.
Clinical Data Manager II in London employer: Cytel
As a Clinical Data Manager II at our esteemed organisation, you will thrive in a dynamic work culture that prioritises collaboration and innovation. We offer competitive benefits, including professional development opportunities and a supportive environment that fosters employee growth. Located in a vibrant area, our company is committed to making a meaningful impact in clinical research, ensuring that your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager II in London
✨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
Show off your skills! Prepare a portfolio that highlights your hands-on data review experience and any projects you've worked on. This can really set you apart during interviews and give potential employers a taste of what you can bring to the table.
✨Tip Number 3
Practice makes perfect! Get ready for those interviews by doing mock sessions with friends or mentors. Focus on common questions related to clinical data management and Medidata Rave. The more comfortable you are, the better you'll perform!
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you. Make sure to tailor your application to highlight your experience with data discrepancies and collaboration with cross-functional teams. Let’s get you that dream job!
We think you need these skills to ace Clinical Data Manager II in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your relevant experience in clinical data management. We want to see how your skills align with the responsibilities listed in the job description, so don’t be shy about showcasing your hands-on data review experience!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical data management and how your background makes you a perfect fit for the Clinical Data Manager II role. We love seeing enthusiasm and a personal touch!
Showcase Your Medidata Rave Skills:Since proficiency in Medidata Rave is key for this role, make sure to highlight any experience you have with it. If you’ve worked on database lock activities or user access management, let us know – we’re keen to see your expertise!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at Cytel
✨Know Your Data Management Stuff
Make sure you brush up on your clinical data management knowledge, especially around Medidata Rave. Be ready to discuss your hands-on experience with data review and how you've tackled discrepancies in past projects.
✨Showcase Your Teamwork Skills
Collaboration is key in this role, so think of examples where you've worked with cross-functional teams. Be prepared to share how you contributed to data cleaning activities and how you communicated with other departments.
✨Understand the Regulatory Landscape
Familiarise yourself with GCP, FDA, and ICH guidelines. During the interview, demonstrate your understanding of these regulations and how they impact clinical data management processes.
✨Prepare for Scenario Questions
Expect questions that put you in real-life situations, like resolving data discrepancies or managing user access. Think through your past experiences and be ready to explain your thought process and actions clearly.
