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- Tasks: Lead the transformation of clinical data management processes and ensure compliance across trials.
- Company: Cytel is a global CRO focused on advancing patient treatment through innovative biostatistical solutions.
- Benefits: Enjoy competitive rewards, comprehensive benefits, and a supportive work environment tailored for your growth.
- Why this job: Be part of a dynamic team driving innovation in clinical development with autonomy and ownership.
- Qualifications: Requires a Bachelor’s degree and 10+ years in clinical data management with leadership experience.
- Other info: Opportunity to transition into a hands-on Clinical Data Manager role post-project completion.
The predicted salary is between 60000 - 84000 £ per year.
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Job Description
Principal Clinical Data Manager
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.
Who Are You?
We are seeking a highly experienced and strategic Principal Clinical Data Manager to contribute to the transformation of data management. This role is pivotal in reengineering core clinical data management workflows, developing comprehensive SOPs and interactive process flows, and ensuring seamless execution across all phases of clinical trials. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you\’ll be at the heart of our client\’s innovation. As a Principal Clinical Data Manager you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. You will be part of the team focused on this transformation initiative with support from both Cytel and our Client. This is an exciting time to be a part of this new program.
Responsibilities
As a Principal Clinical Data Manager, your responsibilities will include:
- Process Reengineering & Oversight:
- Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
- Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
- Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
- Ensure documentation reflects best practices and supports cross-functional understanding and training.
- Oversee the reengineering of critical data management functions, including:
- Study Set-Up
- EDC Build and Maintenance
- Data Cleaning and Query Management
- Local Lab and External Data Handling
- Clinical Coding
- SAE Reconciliation
- Blinding Procedures
- Site Close-Out and Database Lock
- DM Metrics and Clean Patient Tracker
- Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
- Provide subject matter expertise and strategic input to support project planning and execution.
- Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
- Support audit readiness and continuous improvement initiatives.
- Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
- 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.
- Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
- 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.
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Bachelor’s degree in Life Sciences, Health Informatics, or related field
- 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
- Proven expertise in process development, SOP writing, and cross-functional collaboration.
- Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
- Excellent communication, organizational, and problem-solving skills.
An equivalent combination of education and experience may be considered in lieu of stated requirements.
About Us
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.
Seniority level
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Seniority level
Mid-Senior level
Employment type
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Employment type
Full-time
Job function
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Job function
Research, Analyst, and Information Technology
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Industries
Pharmaceutical Manufacturing
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Principal Clinical Data Manager employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Clinical Data Manager
✨Tip Number 1
Network with professionals in the clinical data management field. Attend industry conferences or webinars where you can meet people from Cytel or similar companies. Building relationships can give you insights into the company culture and potentially lead to referrals.
✨Tip Number 2
Familiarise yourself with the latest trends and technologies in clinical data management, especially EDC systems and CDISC standards. Being knowledgeable about these areas will not only boost your confidence but also demonstrate your commitment to staying current in the field.
✨Tip Number 3
Prepare for potential interviews by practising common questions related to process reengineering and cross-functional collaboration. Think of specific examples from your past experience that showcase your leadership skills and ability to drive change.
✨Tip Number 4
Research Cytel's recent projects and initiatives in clinical development. Understanding their goals and challenges will allow you to tailor your discussions during interviews, showing that you are genuinely interested in contributing to their mission.
We think you need these skills to ace Principal Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical data management, especially any leadership roles. Use keywords from the job description to demonstrate that you meet the qualifications and responsibilities outlined by Cytel.
Craft a Compelling Cover Letter: Write a cover letter that showcases your enthusiasm for the role and the company. Discuss your experience with process reengineering and SOP development, and how these skills can contribute to Cytel's mission of advancing treatment options.
Highlight Relevant Skills: In your application, emphasise your expertise in EDC systems, CDISC standards, and regulatory requirements. Provide specific examples of how you've successfully managed data in previous roles to illustrate your capabilities.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical data management.
How to prepare for a job interview at Cytel
✨Showcase Your Leadership Experience
As a Principal Clinical Data Manager, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led teams in the past, particularly in clinical data management. Highlight any specific projects where you reengineered processes or improved workflows.
✨Understand the Regulatory Landscape
Familiarise yourself with the regulatory requirements relevant to clinical data management. Be ready to discuss how you ensure compliance and quality in your work. This will show that you are not only knowledgeable but also proactive in maintaining high standards.
✨Prepare for Cross-Functional Collaboration Questions
Given the collaborative nature of the role, think about your experiences working with different teams. Be prepared to share specific instances where you partnered with other departments to achieve project goals, and how you navigated any challenges that arose.
✨Demonstrate Your Problem-Solving Skills
In this role, you'll face complex challenges. Prepare to discuss situations where you've identified problems and implemented effective solutions. Use the STAR method (Situation, Task, Action, Result) to structure your responses and clearly convey your thought process.
