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- Tasks: Lead data management activities and ensure quality deliverables in clinical studies.
- Company: Join a leading pharmaceutical company focused on innovation and excellence.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in clinical research and drive advancements in healthcare.
- Qualifications: 6+ years in Clinical Data Management with strong RAVE experience required.
- Other info: Collaborative environment with a focus on continuous improvement and industry best practices.
The predicted salary is between 48000 - 72000 £ per year.
Responsibilities include independently leading data management study activities, CRO oversight, and driving deliverable timelines. Strong knowledge of EDC builds utilizing RAVE is essential.
The role represents the 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. The position contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
Key responsibilities involve:
- Partnering with appropriate stakeholders and CRO partners to mitigate and resolve risks.
- Providing input to functional governance with client strategic suppliers.
- Resolving issues escalated from the vendor and/or cross-functional teams.
- Participating in preparing the function for submission readiness and representing the function in formal inspections or audits.
- Ensuring archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Achieving major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics.
- Planning and managing external Data Management budgets and timelines to ensure accuracy, understanding trends in variances, and supporting continuous improvement in forecasting.
- Acting as a process expert for operational and oversight models.
- Maintaining SOPs, process maps, templates, and timelines to support the function's operational and oversight models.
- Preparing metrics to support the function's KPIs.
- Representing the function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc., to identify industry best practices and increase the visibility of the client.
- Contributing to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and align with company, departmental, or functional requirements.
- Ensuring compliance with own Learning Curricula, corporate and/or GXP requirements.
- Working cross-functionally to ensure the quality of the data in each database and on-time delivery, as well as the quality of other data management deliverables.
- Performing other duties as assigned.
Qualifications include proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience, a Bachelor's Degree in a science, health-related, or IT field, and a minimum of 6 years' experience in Clinical Data Management at the CRO or pharma level, including 2 years as a CDM lead. Experience with all phases of development and strong knowledge of data management best practices and technologies is required. Experience with Elluminate is preferred but not required.
Senior Clinical Data Manager employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager
✨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 can’t stress enough how important it is to make those personal connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their values and goals. We recommend practising common interview questions and tailoring your answers to highlight your experience in data management and CRO oversight. Show them you’re the perfect fit!
✨Tip Number 3
Don’t just wait for job postings; be proactive! Reach out directly to companies you admire and express your interest in potential roles. We love when candidates take the initiative, and it shows your enthusiasm for the field.
✨Tip Number 4
Utilise our website to apply for positions. It’s user-friendly and allows you to showcase your skills effectively. Plus, we’re always on the lookout for talented individuals like you, so don’t miss out on the chance to stand out!
We think you need these skills to ace Senior Clinical Data Manager
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 ability to lead data management activities and collaborate with stakeholders. We love a good story!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Use metrics where possible to show how you’ve contributed to successful project outcomes. We appreciate candidates who can quantify their impact!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Cytel
✨Know Your Stuff
Make sure you brush up on your knowledge of EDC builds, especially RAVE. Be ready to discuss your past experiences in Clinical Data Management and how they relate to the responsibilities outlined in the job description.
✨Showcase Your Leadership Skills
Since this role involves leading data management activities and collaborating with stakeholders, prepare examples that highlight your leadership experience. Think about times when you successfully managed a team or resolved conflicts with CRO partners.
✨Be Ready for Technical Questions
Expect questions about data management best practices and technologies. Familiarise yourself with industry standards and be prepared to discuss how you've implemented these in your previous roles.
✨Prepare for Compliance Discussions
Given the importance of compliance in this role, be ready to talk about your experience with inspections, audits, and maintaining TMF documents. Highlight any specific instances where you ensured compliance and readiness for regulatory submissions.
