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- 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 working 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: Collaborative environment with a focus on continuous improvement and industry best practices.
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 in London employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager- FSP 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
Prepare for interviews by brushing up on your RAVE knowledge and data management best practices. Be ready to discuss your past experiences and how they align with the role. Practice common interview questions and think of examples that showcase your leadership skills.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your successful projects and contributions in clinical data management. This can be a great conversation starter during interviews and will help you stand out from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you. Plus, it’s a great way to ensure your application gets seen by the right people. Let’s get you that dream job!
We think you need these skills to ace Senior Clinical Data Manager- FSP in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your expertise in clinical data management and any relevant experience with EDC builds, especially RAVE.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for the Senior Clinical Data Manager role. Share specific examples of how you've led data management activities and collaborated with CROs to meet deliverables.
Showcase Your Leadership Skills: Since this role requires strong leadership, be sure to mention any instances where you've influenced teams or driven projects to success. We want to see how you can contribute to our collaborative environment.
Apply Through Our Website: For the best chance of getting noticed, apply directly through our website. This way, we can easily track your application and ensure it reaches the right people in our team.
How to prepare for a job interview at Cytel
✨Know Your Data Management Inside Out
Make sure you brush up on your clinical data management knowledge, especially around EDC builds and RAVE. Be ready to discuss how you've led data management activities in the past and how you ensured compliance across CROs.
✨Showcase Your Leadership Skills
Prepare examples of how you've influenced cross-functional teams and stakeholders. Highlight specific instances where your leadership helped meet milestones or resolve issues, as this role requires strong collaboration.
✨Understand the Regulatory Landscape
Familiarise yourself with FDA and ICH regulations relevant to data management. Be prepared to discuss how you've navigated these in previous roles, especially in relation to submission readiness and audits.
✨Be Ready for Technical Questions
Expect questions about data management best practices and technologies. Brush up on your knowledge of clinical trial documents and processes, and be ready to explain how you've applied this knowledge in real-world scenarios.