At a Glance
- Tasks: Lead clinical trial operations and enhance delivery through innovative strategies.
- Company: Join Regeneron, a leader in advancing medical research and clinical trials.
- Benefits: Comprehensive health benefits, wellness programs, and generous paid time off.
- Why this job: Make a meaningful impact in clinical trials while driving innovation and collaboration.
- Qualifications: 8+ years in clinical trial operations with strong risk-based monitoring expertise.
- Other info: Inclusive culture with opportunities for professional growth and travel.
The predicted salary is between 43200 - 72000 £ per year.
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We are looking for a Senior Manager, Global Site Management and Monitoring, to join our team and play a pivotal role in coordinating and improving the delivery of clinical trial operations. In this role, you will contribute to the planning, execution, and oversight of our clinical trial portfolio, ensuring collaboration among internal teams, external vendors, and investigator sites. With opportunities to drive innovation and process improvement, this position offers meaningful impact in advancing clinical trial strategies and methodologies.
Responsibilities
- Develop and be responsible for study-specific risk-based monitoring strategies to ensure compliance and efficiency, while managing vendor relationships, including onboarding, performance evaluations and resource alignment.
- Collaborate with Clinical Trial Management teams to design monitoring strategies aligned with RBQM methodologies, including budget planning and approval.
- Provide input to monitoring plans, ensuring alignment with critical data specifications and SDR/SDV approaches.
- Oversee and evaluate performance metrics and risk indicators, providing intervention as needed.
- Act as an SME for monitoring/site management topics, offering guidance to internal and external stakeholders.
- Support inspection readiness activities and participate in regulatory GCP inspections and audits.
Qualifications
This Role May Be For You If:
- You have extensive experience with risk-based quality operating models and clinical trial operations.
- You excel in collaborative environments while maintaining the ability to work independently.
- You are skilled in establishing relationships with stakeholders and translating strategies into actionable frameworks.
- You are familiar with medical terminology and industry regulations, including ICH/GCP standards.
To Be Considered
Applicants must have a Bachelor's Degree and at least 8 years of proven experience in clinical trial operations, monitoring, and site management. A proven understanding of ICH/GCP standards and familiarity with medical terminology are crucial. Preferred qualifications include experience in risk-based monitoring methodologies and expertise in collaborating with CROs and FSPs. This position involves travelling up to 25% of the time to support site management activities.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centres, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
For additional information about Regeneron benefits in the US, please visit. For other countries specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Senior Manager Global Site Management and Monitoring in London employer: BioSpace
Contact Detail:
BioSpace Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Global Site Management and Monitoring in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical trial space and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that fits you perfectly.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of risk-based quality operating models and ICH/GCP standards. We want you to feel confident discussing how your experience aligns with Regeneron's mission and values.
✨Tip Number 3
Showcase your collaborative spirit! During interviews, share examples of how you've successfully worked with internal teams and external vendors. Highlighting your ability to build relationships will set you apart from the competition.
✨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 genuinely interested in joining the Regeneron team and making an impact in clinical trial operations.
We think you need these skills to ace Senior Manager Global Site Management and Monitoring 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 trial operations and risk-based monitoring strategies. 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 this role and how you can contribute to our team. Be sure to mention any relevant experience with vendor relationships and collaboration.
Showcase Your Achievements: Don't just list your responsibilities; showcase your achievements! Use specific examples of how you've improved processes or driven innovation in previous roles. We love seeing measurable impacts!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you get all the updates directly from us!
How to prepare for a job interview at BioSpace
✨Know Your Stuff
Make sure you brush up on your knowledge of risk-based quality operating models and clinical trial operations. Familiarise yourself with ICH/GCP standards and medical terminology, as these will likely come up during the interview.
✨Show Your Collaborative Spirit
Regeneron values teamwork, so be ready to discuss examples of how you've successfully collaborated with internal teams and external vendors in the past. Highlight your ability to build relationships and translate strategies into actionable plans.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills and ability to manage vendor relationships. Think of specific situations where you developed monitoring strategies or improved processes, and be prepared to share those experiences.
✨Ask Insightful Questions
At the end of the interview, have a few thoughtful questions ready about Regeneron's clinical trial strategies or their approach to innovation. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.