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- Tasks: Lead clinical data management projects and mentor junior data managers.
- Company: Join Regeneron, a leader in biotech with a collaborative culture.
- Benefits: Enjoy comprehensive health benefits, fitness perks, and generous paid time off.
- Why this job: Make a real impact in healthcare while advancing your career in a dynamic environment.
- Qualifications: 8-10 years of clinical data management experience and strong leadership skills required.
- Other info: Embrace an inclusive culture with excellent growth opportunities.
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, SOP’s 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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Senior Manager Clinical Data Management Study Lead in London employer: Regeneron Pharmaceuticals
Contact Detail:
Regeneron Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Clinical Data Management Study Lead in London
✨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 researching Regeneron and its projects. Familiarise yourself with their therapeutic areas and recent developments. This shows you’re genuinely interested and ready to contribute from day one!
✨Tip Number 3
Practice your leadership stories! As a Senior Manager, you’ll need to demonstrate your ability to mentor and manage teams. Think of specific examples where you’ve successfully led projects or resolved conflicts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re keen on joining our team at Regeneron and living the Regeneron Way!
We think you need these skills to ace Senior Manager Clinical Data Management Study Lead in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Manager role. Highlight your experience in clinical data management and any relevant therapeutic areas, especially oncology or ophthalmology. We want to see how your skills align with what we’re looking for!
Showcase Leadership Skills: Since this role involves supervising and mentoring, don’t forget to showcase your leadership experience. Share examples of how you've managed teams and improved processes in your previous roles. We love seeing candidates who can inspire others!
Be Detail-Oriented: Attention to detail is key in clinical data management. When writing your application, ensure there are no typos or errors. We appreciate candidates who take the time to present their best selves, as it reflects on their work ethic!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical data management, especially in the therapeutic areas relevant to the role. Familiarise yourself with regulations like CFR, GCP, and ICH Guidelines, as well as the specific EDC applications mentioned in the job description.
✨Showcase Your Leadership Skills
Since this role involves supervising direct reports, be prepared to discuss your previous managerial experience. Think of examples where you've successfully led a team, mentored junior staff, or resolved conflicts. Highlight your ability to set goals and review performance effectively.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and how you handle project planning and issue resolution. Prepare scenarios from your past experiences where you had to allocate resources, manage timelines, or ensure data quality under pressure.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company's data management strategies or their approach to working with CROs and vendors. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.