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Senior Manager, Global Site Management- Clinical Trials

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
Sep 28, 2022
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Job Details

The Senior Manager Global Site Management is a key role within Global Site Management (GSM). Working closely with Clinical Trial Management (CTM) and cross functional study team members the role will also regularly interact with other Development Operations and Portfolio Management (DO&PM) functions, including Global Clinical Trial Services, Development Analytics & Data Science and Vendor & Relationship Management to support execution of the REGN clinical trial portfolio of studies and provide oversight of CRO site management deliverables. In this role you will work closely with CRO partner site management teams, study team members 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 oversee clinical trial delivery at investigator sites for both insourced and outsourced clinical trials. Activities will include evaluation of CRA role resource needs in countries, support onboarding and training of staff members, and handling performance and quality through evaluation of performance metrics and risk indicators which will include direct communication and intervention with study teams, investigator site staff, FSP staff and CRO staff. The role will also support process improvement and innovation projects, will act as delegate for the Head, Global Site Management and/or the Regional Head(s) CTL Strategy and represent Regeneron on the global stage interacting with senior internal and external collaborators.

JOB RESPONSIBILITIES:

  • 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
  • Oversees 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 a number of targeted site co-visits with the study assigned primary CRA (either CRO or REGN FSP) a
  • Aligns and provides support to the CTL team via the Regional Heads  
  • Participates in Risk Based Study execution activities where Global Site Management input and expertise is required in partnership with Global Monitoring Strategy & Oversight (GMSO) and Central Monitoring (CM)
  • Engages cross functional collaborators (eg. SB&C, SSU, CTM) to ensure site activation, enrolment and data entry meets required delivery expectations
  • Establishes a productive professional relationship with CRO counterparts as part of functional oversight responsibilities, working to mitigate and resolve site management related issues
  • Direct performance management and oversight of FSP and CROs through pro-active monitoring of metrics and KPIs, including oversight of onboarding activities
  • Partner with CROs to align on ‘operational health’ messaging at various cross functional and governance forums (eg. Joint Operating Committee, FSP Model Management Team)
  • Acts as a subject matter expert (SME) and REGN point of contact for monitoring/site management topics
  • Identifies issues and applies knowledge, prior experience and critical thinking to make decisions; escalates site management-related issues as necessary
  • Maintains regular communication with key cross functional counterparts and participates in applicable forums/meetings to optimize performance and delivery at investigator sites (eg. CTM, GTO, SSU, VRM)
  • Participates and may lead process improvement initiatives

JOB REQUIREMENTS:

  • Bachelors degree and a minimum of 8 years of related experience
  • Experience managing a Functional Service Provider/Clinical Trial Vendor
  • Problem solving abilities, troubleshooting and critical thinking
  • Analytical problem-solving experience
  • Working understanding of clinical drug development process as well as ICH GCP
  • Effective communication and social skills; ability to establish relationships internally and externally
  • Familiarity with medical terms
  • Demonstrates writing skills to deliver messages effectively so messages are clearly understood
  • Proficiency in required IT applications (includes EDC, CTMS, data repositories and MS Office applications)

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 amazing benefits including health and wellness programs, fitness centers and stock 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.

#GDDOPMJobs

#LI-Hybrid

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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