Clinical Study Associate Manager

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 85,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate Manager to join our Clinical Trial management team in the United States.

You will support the Clinical Study Lead across internally sourced and CRO-staffed studies, collaborating with vendors and the internal study team to deliver trial milestones. Responsibilities include leading study planning, risk assessment, document development, system setup (CTMS, TMF), vendor engagement, recruitment strategies, and budget management.

Qualifications

• Bachelor's degree and 4+ years of relevant industry experience.
• Proficient with trial management systems and MS Office applications.
• Knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• Lead/oversee planning and management of a clinical study in assigned region(s) in alignment with global study plans.
• Contribute to risk assessment and mitigation strategies and support feasibility assessments.
• Develop and review study documents (CRF, data management plan, monitoring plan).
• Set up and maintain study systems (CTMS, TMF) and support investigator meeting prep.
• Engage, contract and manage vendors; oversee drug forecasting and reconciliation.
• Provide regular status reports and help develop recruitment/retention strategies.
• Monitor site recruitment, activation, and monitoring visits; ensure data quality.
• Oversee study close-out activities including database lock, budget reconciliation, and TMF.

Skills

Data-driven problem solving

Attention to detail

Budget awareness

Vendor management

ICH/GCP knowledge

Education

Bachelor's degree

Tools

MS Office (Project, PowerPoint, Word, Excel)

Trial management systems

EDC

TMF/CTMS

IVRS/IWRS

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Associate Manager to join our Clinical Trial management team. In this role, you will support the Clinical Study Lead by taking responsibility for areas of clinical trial delivery, applying to both internally sourced studies and studies out-sourced to CROs, while collaborating with the study team internally and externally with vendors such as CROs.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Armonk, NY, Warren, NJ, Cambridge, MA

Travel percentage: May require 25% travel

Discover your role:

• May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study
• Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
• Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials
• Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
• Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation
• Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies
• Monitors recruitment and retention, and monitors progress for site activation and monitoring visits
• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites, and escalates data flow and data quality issues to Clinical Study Lead
• Oversees the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes
• Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required
• Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact)

This role requires:

• Bachelor's Degree and 4+ years of relevant industry experience
• A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities
• Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
• Budget awareness with the ability to participate in various aspects of budget management
• Familiarity with medical terms, and vendor management experience
• Experience in clinical trial operations including experience developing key study documents
• Knowledge of ICH/GCP and regulatory guidelines/directives

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Re