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- Tasks: Lead data management activities and ensure high-quality deliverables in clinical studies.
- Company: Join Cytel Inc., a leader in clinical data insights and analytics.
- Benefits: Enjoy a competitive salary, remote work options, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by managing critical data for clinical trials.
- Qualifications: Proven experience as a Lead Clinical Data Manager with strong RAVE knowledge.
- Other info: Be part of a diverse team committed to innovation and excellence.
The predicted salary is between 48000 - 72000 £ per year.
Responsible for independently leading 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. Ensures 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. Performs other duties as assigned.
Qualifications:
- Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience.
- Bachelor's Degree in a science, health related, or IT field.
- Minimum 6 years' experience in Clinical Data Management at the CRO or pharma level.
- 2 years as a CDM lead.
- Experience with all phases of development.
- Strong knowledge of data management best practices and technologies.
- Experience with Elluminate is not required but preferred.
Senior Clinical Data Manager employer: Cytel Inc
Contact Detail:
Cytel Inc 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, especially those who work at Cytel or similar companies. A friendly chat can sometimes lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your RAVE knowledge and data management best practices. We recommend doing mock interviews with friends or using online platforms to get comfortable discussing your experience and how it aligns with the role.
✨Tip Number 3
Showcase your leadership skills! During interviews, share specific examples of how you've led teams or projects in the past. Highlighting your ability to drive deliverables and manage timelines will make you stand out.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team at Cytel.
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 held in data management. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about data management and how your experience makes you a perfect fit for our team. Don’t forget to mention any relevant projects or achievements that showcase your expertise.
Showcase Your Leadership Skills: Since this role involves leading data management activities, be sure to highlight your leadership experience. Share examples of how you've successfully managed teams or projects, and how you've collaborated with stakeholders to meet deliverables.
Apply Through Our Website: We encourage you to apply directly 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 us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Cytel Inc
✨Know Your RAVE Inside Out
Since the role requires strong knowledge of EDC builds using RAVE, make sure you brush up on your technical skills. Be prepared to discuss specific projects where you've successfully implemented RAVE and how it contributed to data management efficiency.
✨Showcase Your Leadership Skills
This position involves influential leadership and collaboration with stakeholders. Think of examples from your past experiences where you led a team or project, resolved conflicts, or drove deliverables. Highlight how you ensured quality and met timelines.
✨Understand the Bigger Picture
Familiarise yourself with the clinical development process and how data management fits into it. Be ready to discuss how you can contribute to key decision points and regulatory submissions, as well as your approach to ensuring compliance and readiness for inspections.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities, especially regarding risk mitigation and issue resolution. Prepare scenarios where you successfully navigated challenges with CROs or cross-functional teams, demonstrating your strategic thinking and adaptability.
