Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead clinical data management activities and ensure compliance across multiple CROs.
- Company: Join a leading company in clinical data management with a commitment to innovation.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Why this job: Make a real impact in clinical trials and contribute to groundbreaking healthcare solutions.
- Qualifications: Bachelor's degree and 6+ years in Clinical Data Management, with strong RAVE experience.
- Other info: Dynamic role with opportunities for continuous improvement and industry engagement.
The predicted salary is between 48000 - 72000 £ per year.
The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, and data management plan, and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs.
Responsibilities
- Independently lead data management study activities, CRO oversight, and driving deliverable timelines.
- Strong knowledge of EDC builds utilizing RAVE.
- Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Contributes influential leadership in collaboration with other client Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provides input to functional governance with client strategic suppliers.
- Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
- Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Participates and represents function in formal inspections and audits as requested.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
- Acts as a process expert for operational and oversight models.
- Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
- May prepare metrics to support the function’s KPIs.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
- Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
- Utilizing your strong communication skills to present and explain data management concepts and consequences of decisions.
- Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience.
Qualifications
- Bachelor's Degree in a science, health related, or information technology field required.
- Minimum 6 years experience in Clinical Data Management with at least 3 as a Lead.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Strong knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Senior Clinical Data Manager- FSP employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager- FSP
✨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
Prepare for interviews by brushing up on your RAVE knowledge and data management best practices. Be ready to discuss your experience with CRO oversight and how you’ve tackled challenges in past projects. Confidence is key!
✨Tip Number 3
Showcase your leadership skills! When chatting with potential employers, highlight times when you’ve led teams or projects. They want to see that you can drive deliverables and manage timelines effectively.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented individuals like you. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace Senior Clinical Data Manager- FSP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Clinical Data Manager role. Highlight your experience with EDC builds, especially RAVE, and any leadership roles you've had in data management. We want to see how your skills align with what we're looking for!
Showcase Your Experience: In your cover letter, don’t just list your qualifications; tell us about your hands-on experience in clinical data management. Share specific examples of how you've led projects or resolved issues, as this will help us understand your impact in previous roles.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate straightforward communication, especially when it comes to complex topics like data management.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to track your application and ensure it reaches the right people. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at Cytel
✨Know Your Data Management Inside Out
Make sure you have a solid grasp of the clinical data management process, especially from study start-up to database lock. Brush up on your knowledge of EDC builds, particularly RAVE, as this will be crucial in demonstrating your expertise during the interview.
✨Showcase Your Leadership Skills
Be prepared to discuss your experience in leading data management activities and overseeing CROs. Highlight specific examples where you've driven deliverable timelines and ensured compliance, as this will show your ability to take charge and lead teams effectively.
✨Understand the Bigger Picture
Familiarise yourself with the cross-functional interfaces involved in data management. Be ready to explain how you’ve collaborated with other stakeholders to meet milestones and deliverables, as this will demonstrate your strategic thinking and teamwork skills.
✨Prepare for Compliance Questions
Since compliance is key in this role, review relevant FDA and ICH regulations. Think of instances where you've ensured compliance in your previous roles, and be ready to discuss how you would maintain inspection readiness for all Data Management Trial Master File documents.
