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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: Collaborative environment with a strong emphasis on continuous improvement.
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 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
✨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 EDC knowledge, especially RAVE. Be ready to discuss your past experiences and how they relate to the role. Practice common interview questions and think of examples that showcase your leadership and problem-solving skills.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your successful projects in clinical data management. Include metrics and outcomes to demonstrate your impact. This can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! We’re always looking for talented individuals like you. Keep an eye on our job postings and make sure your application stands out by tailoring it to the specific role you’re interested in.
We think you need these skills to ace Senior Clinical Data Manager- FSP
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 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 clinical data management and how your background makes you a perfect fit for our team. Don’t forget to mention your experience with CRO oversight and compliance activities.
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your ability to lead data management activities and meet deliverables. We love numbers, so if you can quantify your successes, even better!
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 you’re keen on joining StudySmarter!
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 likely come up in conversation.
✨Showcase Your Leadership Skills
Be prepared to discuss your experience in leading data management activities and overseeing CROs. Think of specific examples where you've driven deliverable timelines and ensured compliance across multiple programs.
✨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 to meet milestones and deliverables, especially in relation to regulatory submissions.
✨Prepare for Compliance Questions
Since compliance is key in this role, review your knowledge of FDA and ICH regulations. Be ready to discuss how you've ensured inspection readiness and maintained SOPs in your previous roles.
