At a Glance
- Tasks: Lead clinical data management projects and mentor junior data managers for skill advancement.
- Company: Join Regeneron, a leader in biotech with a commitment to innovation and quality.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on teamwork and independent problem-solving.
- Why this job: Make a real impact in healthcare by ensuring data quality and efficiency.
- Qualifications: Bachelor’s degree and 8-10 years of clinical data management experience required.
The predicted salary is between 60000 - 80000 £ per year.
The Senior Manager, Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management results that meet Regeneron standards and within timelines.
A Typical Day Might Include The Following:
- Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution.
- Projects, allocates and prioritises DM resources within the assigned therapeutic projects.
- Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality results and within the budget.
- Mentors junior data managers for skills advancement.
- If required, leads and performs clinical data management tasks for studies.
- Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOPs and work instructions in compliance with applicable regulations.
- Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects.
- Designs and modifies CRF.
This Role Might Be For You If:
- Supervises DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
- Coordinates with clinical project team for issue resolution.
- Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardisation.
- Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.
- Establishes goals, expectations and accountabilities for direct reports.
- Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures.
- Responsible for coaching, handling training and leading the direct reports.
To be considered:
- Bachelor’s degree in mathematics, Science or a related field, along with at least 8-10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry.
- Previous oncology and/or ophthalmology experience a plus.
- Previous managerial experience is preferred.
- Directed and comfortable working in teams with the ability to work and operate independently within a tight timeline environment.
- High degree of creativity, latitude and attention to detail required.
- Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines.
- Strong communication, leadership and business development skills required.
- Proficient with appropriate EDC applications and Microsoft Office applications.
- Software proficiency with CDMS required.
- Experience with JMP and SAS a plus.
Senior Manager Clinical Data Management Study Lead in Uxbridge employer: Regeneron
Regeneron is an exceptional employer that fosters a collaborative and innovative work culture, providing employees with the opportunity to lead impactful clinical data management projects in a dynamic environment. With a strong emphasis on mentorship and professional development, employees are encouraged to grow their skills while contributing to cutting-edge research in biotechnology. Located in a vibrant area, Regeneron offers competitive benefits and a commitment to diversity and inclusion, making it a rewarding place for those seeking meaningful careers in the health-related industry.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Clinical Data Management Study Lead in Uxbridge
✨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 to potential employers. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by researching Regeneron and their projects. Understand their therapeutic areas and be ready to discuss how your experience aligns with their needs. We want you to show them you’re not just another candidate, but the perfect fit for their team!
✨Tip Number 3
Practice your leadership skills! As a Senior Manager, you’ll need to demonstrate your ability to mentor and manage teams. Think of examples from your past where you’ve successfully led projects or developed junior staff. We want to see that you can inspire others!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us. Let’s get you on board!
We think you need these skills to ace Senior Manager Clinical Data Management Study Lead in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Senior Manager role. Highlight your clinical data management experience, especially in oncology or ophthalmology, to catch our eye!
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 projects you've led and how they relate to the responsibilities outlined in the job description.
Showcase Your Leadership Skills:Since this role involves mentoring and supervising, be sure to highlight your leadership experience. Share examples of how you've successfully managed teams and improved processes in your previous roles.
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 our team!
How to prepare for a job interview at Regeneron
✨Know Your Data Management Stuff
Make sure you brush up on your clinical data management knowledge, especially around regulations like CFR, GCP, and ICH Guidelines. Be ready to discuss how you've applied these in past roles, particularly in oncology or ophthalmology if you have that experience.
✨Show Off Your Leadership Skills
Since this role involves supervising and mentoring junior data managers, be prepared to share examples of how you've led teams in the past. Talk about your approach to setting goals, managing performance, and resolving conflicts within a team.
✨Be Ready for Problem-Solving
Expect questions that assess your ability to handle project planning and issue resolution. Think of specific challenges you've faced in previous projects and how you navigated them, especially when coordinating with clinical project teams.
✨Familiarise Yourself with EDC Applications
Since proficiency with EDC applications is crucial, make sure you can discuss your experience with relevant software like CDMS, JMP, and SAS. If you’ve used any specific tools in your previous roles, highlight those to show your technical expertise.
