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- 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, with RAVE experience.
- Other info: Collaborative environment with a commitment to 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.
As a Clinical Data Manager, your responsibilities will include:
- Independently lead data management study activities, CRO oversight, and driving deliverable timelines.
- Strong knowledge of EDC builds utilizing RAVE.
- Represent 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.
- Contribute influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Provide input to functional governance with client strategic suppliers.
- Participate in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensure 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.
- Act as a process expert for operational and oversight models.
- Maintain SOPs, process maps and templates and timelines to support functions operational and oversight models.
- May prepare metrics to support the function's KPIs.
- Represent function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of client.
- Contribute 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.
- Work 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.
- Utilize 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. 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 and 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 City of Westminster employer: Cytel (EMEA)
Contact Detail:
Cytel (EMEA) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager- FSP in City of Westminster
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their values and goals. We recommend practising common interview questions and even role-playing with a friend. The more prepared you are, the more confident you'll feel when it’s time to shine!
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss your experience with EDC builds and data management processes. We want to hear about your successes and how you've tackled challenges in previous roles—this is your chance to impress!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us. Let’s make it happen together!
We think you need these skills to ace Senior Clinical Data Manager- FSP in City of Westminster
Some tips for your application 🫡
Show Off Your Experience: When you're writing your application, make sure to highlight your experience in clinical data management. We want to see how you've led data management activities and your familiarity with EDC builds, especially RAVE. Don't be shy about showcasing your achievements!
Tailor Your Application: Take a moment to tailor your application to the job description. Use keywords from the posting, like 'CRO oversight' and 'data validation'. This shows us that you understand what we're looking for and that you're genuinely interested in the role.
Be Clear and Concise: Keep your application clear and to the point. We appreciate straightforward communication, so avoid jargon unless it's relevant. Make it easy for us to see your qualifications and how they align with the role of Senior Clinical Data Manager.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It helps us keep track of applications and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Cytel (EMEA)
✨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 across multiple programs, as this will show your capability to handle the responsibilities of the role.
✨Understand the Bigger Picture
Familiarise yourself with the cross-functional interfaces involved in data management. Be ready to explain how you’ve collaborated with stakeholders and other teams to meet milestones and deliverables, as this will demonstrate your ability to work effectively in a team environment.
✨Prepare for Compliance Questions
Since compliance is key in this role, review FDA and ICH regulations related to data capture and management processes. Be ready to discuss how you've ensured compliance in past projects, as this will highlight your attention to detail and commitment to quality.
