Job Description
The Senior Manager, Global Site Clinical Operations is a key role working closely with Clinical Trial Management (CTM) and cross functional study team members. Regularly interacts with other Development Operations and Portfolio Management (DO&PM) functions, including Global Clinical Trial Services, Development Analytics & Data Science, CTM, and Vendor & Relationship Management to support execution of the REGN clinical trial portfolio of studies and provide oversight of CRO site management deliverables. Collaborate with site management teams, study team including the Program Operations Leads (POL) and Clinical Study Leads (CSL), the REGN GSM functional service provider(s) and the team of Clinical Trial Liaison (CTL) to lead all aspects of trial delivery at investigator sites for both insourced and outsourced clinical trials. Activities include: the evaluation of CRA resource needs in countries, support onboarding and training of staff members, handling performance and quality through evaluation of performance metrics & risk indicators. Direct communication and intervention with study teams, investigator site staff, FSP staff and CRO staff. The role acts as delegate for the Head, Global Site Management and/or the Regional Head(s) CTL Strategy and represents Regeneron globally interacting with senior internal and external partners.
As a Senior Manager Global Site Clinical Operations, a typical day might include the following:
- Supports all REGN site management activities to ensure compliance to the protocol, monitoring plan, ICH GCP, REGN SOPs, and local operational and regulatory requirements (SQV, SIV, IMV and COV).
- Provides oversight of CRO partner site management activities, including CRO CRA engagement activities, review of CRO CRA resource allocation and performance.
- Coordinates with CRO partner and FSP CRAs to ensure sites meet performance expectations related to study delivery, including subject identification, enrollment, retention, and timely delivery of quality data.
- Supports establishing productive investigator site relationships through attending various targeted site co-visits with the study assigned primary CRA (either CRO or REGN FSP).
- Aligns and provides support to the CTL team via the Regional Heads.
This role might be for you if:
- You are a problem solver
- You like to be analytical when it comes to your approach each day
- Effective communication and interpersonal skills; ability to establish relationships internally and externally.
- Familiarity with medical terms.
To be considered, you must have at least 8 years of related experience and strong knowledge of drug development and ICH GCP.
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.