The Sr. Manager Global Monitoring Oversight will be responsible for the development, execution and oversight of study risk-based monitoring strategies. The role sits in Global Monitoring and reports into the Head of Clinical Monitoring. The incumbent will collaborate with Clinical Trial Management study teams to design fit-for-purpose monitoring specifications, review CRO bids and strategy proposals, act as operational lead for study risk assessment (QRACT) process, and derive the final study risk-based monitoring strategy and associated costs for studies conducted in Development Operations & Portfolio Management.
The role will collaborate closely with Clinical Trial Management, Central Oversight Monitoring, GCP Quality, Strategic Sourcing and Procurement and Business Operations.
A typical day may include:
Attending Expanded Synopsis (ES) planning and design meetings as a Strategic Monitoring subject matter authority to provide relevant input on initial protocol de-risking and the proposed monitoring strategy
Facilitating the Quality and Risk Assessment process using cross functional input to complete the study specific QRACT after Expanded Synopsis approval
Creating a study specific monitoring strategy which includes, but is not only limited to the identification of critical data and process, consulting on data review methods (including Key Risk Indicators and appropriate detection approaches) and the study specific monitoring visit strategy
Providing monitoring functional expertise to support study budget planning and approval as well as subsequent change orders and ongoing study budget assessments
Ensuring translation of derived monitoring strategy into Clinical Monitoring Plan and shares with CRO partners and/or Regeneron clinical study teams
This job may be for you if you have:
Experience of working in a risk based quality operating model and extensive experience in global clinical trial operations required
Extensive medical and scientific knowledge and clinical development understanding
Ability to establish relationships with internal collaborators
Ability to translate a design strategy into an operating framework
Critical thinker, proactive and self-motivated
A working understanding of ICH/GCP
- Strong organizational skills with effective use of time and prioritization
Ability to travel 25% travel required
To be considered you must have a Bachelors Degree and a minimum of 8 years relevant industry and/or CRO experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$117,700.00 - $192,100.00