Clinical Study Operations Director

3 days ago

Dublin, Dublin City, Ireland Regeneron Ireland DAC Full time

Role Overview

The Clinical Study Operations Director will oversee the execution of clinical trials from design through to study close out. The role requires strategic leadership, strong communication skills, and the ability to manage cross-functional teams.

Main Responsibilities

  • Provide operational input into protocol development
  • Oversight of study-specific documentation, including case report forms, data management plans, and monitoring plans
  • Set-up and maintenance of study systems, including CTMS and TMF
  • Ensure compliance with clinical trial registry requirements
  • Lead and oversee engagement, contracting, and management of required vendors
  • Develop and manage study budgets and timelines
  • Lead risk assessment and identify mitigation strategies
  • Oversee site evaluation and selection, investigator meetings, and monitoring visits
  • Develop and implement patient recruitment and retention strategies
  • Monitor data entry and query resolution
  • Escalate issues related to study conduct, quality, timelines, or budget
  • Oversee execution of clinical studies against planned timelines, deliverables, and budget
  • Data quality oversight, including regular review of data metrics and listings
  • Ensure CROs and third-party vendors are in alignment and delivering per scope of work
  • Support internal audit and external inspection activities
  • Manage study close-out activities, including database lock, vendor contract reconciliation, and study drug accountability

Required Skills and Qualifications

  • Bachelor's degree required; 6+ years of direct clinical trial experience
  • Demonstrated interpersonal and leadership skills
  • Ability to understand and implement operational strategic direction and guidance for respective clinical studies
  • Data-driven approach to planning, executing, and problem-solving
  • Effective communication skills via verbal, written, and presentation abilities
  • Proactive and self-disciplined, with ability to meet deadlines, effective use of time, and prioritization
  • Ability to influence and negotiate across key stakeholders
  • Budget management experience
  • Awareness of relevant industry trends
  • Technical proficiency in trial management software and MS applications

Benefits

Regeneron offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Culture and Values

Regeneron is an equal opportunity employer and values diversity, inclusion, and respect in the workplace.

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