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For Companies At a Glance
- Tasks: Lead global data management activities and ensure high-quality deliverables for clinical trials.
- Company: Join a leading organisation in the healthcare sector focused on innovation and excellence.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for professional growth.
- Why this job: Make a significant impact in drug development while collaborating with top industry professionals.
- Qualifications: 8+ years in data management with strong project management skills required.
- Other info: Dynamic work environment with a focus on continuous improvement and compliance.
The predicted salary is between 72000 - 108000 £ per year.
Overview
Key responsibilities may include:
- Responsible for vendor oversight activities across global development programs.
- 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 or leads 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.
Educational qualifications
MS or BS in health-related, life sciences area or technology-related field.
Minimum Work Requirements
- Minimum of 8 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
- Experience with all phases of development in one or more therapeutic areas preferred.
- Ability to handle multiple development programs simultaneously.
- NDA/CTD Experience 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.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
Principal Clinical Data Manager in London employer: Cytel - EMEA
Contact Detail:
Cytel - EMEA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Clinical Data Manager in London
✨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 personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your experience. We recommend practising common interview questions and even role-playing with a friend to boost your confidence.
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss specific projects or challenges you've tackled in data management. We want you to highlight your problem-solving skills and how you’ve contributed to successful outcomes in previous roles.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression. We suggest reiterating your enthusiasm for the role and mentioning something specific from the conversation to keep you fresh in their minds.
We think you need these skills to ace Principal Clinical Data Manager in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal Clinical Data Manager role. Highlight your experience in data management and drug development, and don’t forget to showcase your project management skills. We want to see how you’ve made an impact in previous roles!
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 position. Mention specific experiences that align with the responsibilities listed in the job description. We love seeing genuine enthusiasm for the role!
Showcase Your Leadership Skills: Since this role involves influential leadership, make sure to highlight any relevant leadership experiences. Talk about how you've collaborated with stakeholders or led initiatives in your past roles. We’re looking for someone who can drive results and inspire others!
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 gives you a chance to explore more about StudySmarter and what we stand for!
How to prepare for a job interview at Cytel - EMEA
✨Know Your Data Management Inside Out
Make sure you brush up on your knowledge of data management best practices and technologies. Be ready to discuss how you've applied these in previous roles, especially in relation to clinical trials. This will show that you’re not just familiar with the theory but have practical experience too.
✨Prepare for Cross-Functional Collaboration Questions
Since this role involves working closely with various stakeholders, think about examples from your past where you successfully collaborated across teams. Prepare to share specific instances where you mitigated risks or resolved issues, as this will demonstrate your ability to lead and influence effectively.
✨Familiarise Yourself with Regulatory Standards
Given the importance of compliance in this role, ensure you’re well-versed in FDA and ICH regulations. Be prepared to discuss how you’ve ensured compliance in your previous projects, as this will highlight your attention to detail and understanding of industry standards.
✨Showcase Your Project Management Skills
With a minimum of 8 years required, be ready to talk about your project management experience. Highlight specific large drug development programmes you’ve managed, focusing on how you handled budgets, timelines, and deliverables. This will illustrate your capability to oversee complex projects successfully.
