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 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 employer: Cytel
As a Clinical Data Manager II at our company, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. We offer competitive benefits, a collaborative culture, and opportunities to engage with cross-functional teams, ensuring that your contributions are valued and impactful. Located in a vibrant area, our workplace fosters innovation and encourages a healthy work-life balance, making it an excellent choice for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Data Manager II
✨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! If you’ve got experience with Medidata Rave, make sure to highlight that in conversations. Bring it up during networking chats or interviews to demonstrate your hands-on expertise and how it aligns with what employers are looking for.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of GCP, FDA, and ICH guidelines. Be ready to discuss how you’ve applied these in your previous roles. This will show potential employers that you’re not just a fit on paper but also in practice.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you. Plus, applying directly can sometimes give you a leg up in the hiring process. So, get your application in and let’s get you that Clinical Data Manager II role!
We think you need these skills to ace Clinical Data Manager II
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your clinical data management experience and proficiency in Medidata Rave. We want to see how your skills match the job description, so don’t be shy about showcasing relevant projects or achievements!
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 our team. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Attention to Detail:As a Clinical Data Manager II, accuracy is key. In your application, highlight specific examples where you’ve successfully identified and resolved data discrepancies. This will show us that you have the meticulous nature we’re looking for!
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.
✨Show Off 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’ve supported data cleaning activities and contributed to successful database lock processes.
✨Understand the Regulations
Familiarise yourself with GCP, FDA, and ICH guidelines. During the interview, demonstrate your understanding of these regulatory requirements and how they impact clinical data management practices.
✨Be Ready 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.
