Clinical Study Associate Manager

Initial Therapeutics, Inc.; Armonk (NY); Hybrid; USD 109,900 - 179,300; Full time

Job summary

Regeneron in the United States is seeking a Clinical Study Associate Manager to join the Clinical Trial management team in Armonk, NY. You will support the Clinical Study Lead by managing trial delivery across internally sourced and CRO-led studies, coordinating with vendors and study teams worldwide.

The role offers hybrid work four days on site, up to 25% travel and opportunities to contribute to risk assessment, study documentation, CTMS/TMF setup, recruitment strategies and data quality

Qualifications

• Bachelor's Degree and 4+ years of relevant industry experience.
• Excellent communication and interpersonal skills; ability to build relationships internally and externally.
• 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.

Responsibilities

• 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)

Skills

Communication skills

Interpersonal skills

Data-driven problem solving

Time management

Budget management

Vendor management

Regulatory knowledge

Education

Bachelor's Degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

CTMS

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
• Hybrid: 4 days per week onsite
• 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
• Excellent communication and interpersonal skills; ability to build relationships internally and externally
• 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
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Salary Range (annually)

$109,900.00 - $179,300.00