At a Glance
- 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 a 401(k) match.
- Other info: Work in a dynamic environment with opportunities for growth and development.
- Why this job: Make a real impact in healthcare while advancing your career.
- Qualifications: 8-10 years in clinical data management and strong leadership skills 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.
Responsibilities
- 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
- Bachelors 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.
Apply now to take your first step towards living the Regeneron Way!
Senior Manager Clinical Data Management Study Lead employer: BioSpace
Regeneron is an exceptional employer that fosters a collaborative and inclusive work culture, providing comprehensive benefits tailored to support employee well-being and professional growth. With a strong emphasis on mentorship and career advancement, particularly for those in clinical data management roles, employees are empowered to thrive in a dynamic environment that values creativity and attention to detail. Located in a vibrant area, Regeneron offers unique opportunities to engage with cutting-edge research while enjoying a supportive community.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Clinical Data Management Study Lead
✨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 asking for introductions. We all know someone who knows someone, so leverage that to get your foot in the door.
✨Tip Number 2
Prepare for interviews by researching Regeneron and its projects. Understand their values and how they align with your experience. We want you to show that you’re not just another candidate; you’re the perfect fit for their team!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to leadership and project management. We recommend doing mock interviews with friends or mentors to build confidence and refine your answers.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. Plus, it’s a great opportunity to reiterate why you’d be an asset to their team.
We think you need these skills to ace Senior Manager Clinical Data Management Study Lead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager role. Highlight your clinical data management experience and any relevant therapeutic areas you've worked in. 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 previous experiences make you a great fit for our team. Keep it engaging and personal!
Showcase Your Leadership Skills:Since this role involves supervising and mentoring, be sure to highlight your leadership experience. Share examples of how you've successfully managed teams or projects in the past. We love seeing candidates who can 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 shows you’re serious about joining our team at Regeneron!
How to prepare for a job interview at BioSpace
✨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 software tools 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, resolved conflicts, or mentored junior staff. This will demonstrate your capability to manage and inspire others.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle tight timelines. Prepare scenarios from your past experiences where you had to allocate resources effectively or resolve issues within a project. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about the company's data management strategies or how they measure success in this role. This shows your genuine interest in the position and helps you gauge if the company is the right fit for you.
