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For Companies At a Glance
- Tasks: Lead data management for clinical studies, ensuring quality and compliance.
- Company: Join a dynamic biotech company focused on innovation and growth.
- Benefits: Enjoy remote work options, competitive salary, and great perks.
- Why this job: Make a real impact in clinical development while collaborating with diverse teams.
- Qualifications: Must have significant experience in clinical data management and CRO oversight.
- Other info: Stay ahead of industry trends and drive improvements in data practices.
The predicted salary is between 48000 - 84000 £ per year.
Overview
We are seeking an experienced Clinical Data Manager to join our Clinical Operations team. In this pivotal role, you will oversee and manage fully outsourced data management activities to ensure high-quality, timely, and compliant clinical data to support regulatory submissions and clinical development goals. This is a new role where you will take ownership of data oversight across all clinical studies. You will collaborate closely with CROs, vendors, internal cross-functional teams, and external stakeholders to ensure data integrity and operational excellence.
Key Responsibilities
- Serve as the primary data management contact for assigned clinical studies.
- Oversee CROs and vendors to ensure timely, high-quality delivery of all data management activities in compliance with GCP, ICH, and regulatory requirements.
- Review and approve essential data management documentation, including Data Management Plans (DMPs) and validation specifications.
- Ensure efficient execution of database go-live, interim reviews, and database lock processes.
- Monitor data quality and resolve issues proactively to maintain data integrity.
- Support regulatory submissions by ensuring availability of clean, compliant datasets.
- Stay current with industry standards and regulatory trends to drive continuous improvement in data management practices.
Must Haves
- Significant clinical data management experience, preferably in a biotech or pharmaceutical environment.
- Experience overseeing fully outsourced data management with CRO oversight.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva EDC, Oracle Inform) and data review tools.
Why Join Us?
- Make a significant impact in an innovative and growing biotech company .
- Collaborative and innovative work environment.
- Competitive salary and benefits package.
- Remote working with regular team meetings.
Senior Clinical Data Manager employer: Northreach
Contact Detail:
Northreach Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Data Manager
✨Tip Number 1
Network with professionals in the clinical data management field. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends. This can help you gain insights into what companies like us are looking for in candidates.
✨Tip Number 2
Familiarise yourself with the specific EDC systems mentioned in the job description, such as Medidata Rave or Veeva EDC. Consider taking online courses or tutorials to enhance your proficiency, as this will demonstrate your commitment and readiness for the role.
✨Tip Number 3
Stay updated on the latest GCP and ICH guidelines. Subscribe to relevant newsletters or join professional organisations that focus on clinical data management. This knowledge will not only prepare you for interviews but also show us that you are proactive about your professional development.
✨Tip Number 4
Prepare to discuss your experience with CRO oversight during interviews. Think of specific examples where you successfully managed outsourced data management activities, as this will highlight your ability to take ownership and ensure compliance with regulatory requirements.
We think you need these skills to ace Senior Clinical Data Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your significant clinical data management experience, especially in biotech or pharmaceutical environments. Emphasise your proficiency with EDC systems and your understanding of GCP and ICH guidelines.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Discuss your experience overseeing outsourced data management and how you ensure compliance with regulatory requirements. Be specific about your achievements in previous roles.
Highlight Relevant Skills: When detailing your skills, focus on those that align with the job description, such as data integrity monitoring, database management processes, and collaboration with CROs and vendors. Use examples to demonstrate your expertise.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in this role.
How to prepare for a job interview at Northreach
✨Showcase Your Experience
Be prepared to discuss your significant clinical data management experience in detail. Highlight specific projects where you oversaw outsourced data management and how you ensured compliance with GCP and ICH guidelines.
✨Demonstrate Your Knowledge of Regulatory Requirements
Familiarise yourself with the latest regulatory trends and standards in clinical data management. Be ready to explain how you have applied this knowledge in previous roles to maintain data integrity and support regulatory submissions.
✨Discuss Your Collaboration Skills
Since this role involves working closely with CROs, vendors, and internal teams, prepare examples that demonstrate your ability to collaborate effectively. Share instances where you resolved conflicts or improved communication to enhance project outcomes.
✨Prepare for Technical Questions
Expect questions about your proficiency in EDC systems and data review tools. Brush up on your technical skills and be ready to discuss how you've used these tools to manage data quality and streamline processes in past projects.
