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For Companies At a Glance
- Tasks: Lead clinical data management activities and ensure compliance across multiple CROs.
- Company: Join a leading organisation in the clinical research field with a focus on innovation.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a significant impact on clinical trials and improve patient outcomes.
- Qualifications: Bachelor's degree and 6+ years in Clinical Data Management required.
- Other info: Dynamic role with opportunities to influence 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, & 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 Inc
Contact Detail:
Cytel Inc 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 industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Clinical Data Manager role.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your experience with EDC builds and CRO oversight. Show them you’re the perfect fit for their team!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to remind them why you’re the ideal candidate for the job.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications this way!
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 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 our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that demonstrate your understanding of clinical data management processes and your ability to lead teams effectively.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics or examples to illustrate how you’ve contributed to successful data management projects in the past. We love seeing how you’ve made an impact!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, it helps us keep track of your application!
How to prepare for a job interview at Cytel Inc
✨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
Prepare examples that highlight your experience in leading data management activities and overseeing CROs. Be ready to discuss how you've driven deliverable timelines and ensured compliance across multiple programs, as this will show your ability to manage complex projects effectively.
✨Understand the Regulatory Landscape
Familiarise yourself with FDA and ICH regulations relevant to data management. Being able to discuss how these regulations impact your work will not only impress the interviewers but also demonstrate your commitment to maintaining high standards in clinical trials.
✨Communicate Clearly and Confidently
Since strong communication skills are essential for this role, practice explaining complex data management concepts in simple terms. Prepare to discuss how you've collaborated with stakeholders and resolved issues, as this will showcase your ability to work cross-functionally and lead discussions effectively.