Clinical Operations Director

2 weeks ago


Crawley, West Sussex, United Kingdom Albion Rye Associates Full time
Job Title: Clinical Operations Director

At Albion Rye Associates, we are seeking a highly skilled Clinical Operations Director to lead our clinical trials team. As a key member of our organization, you will be responsible for overseeing the day-to-day operations of clinical trials, ensuring adherence to GCP, regulatory requirements, and company SOPs.

Key Responsibilities:
  • Lead, manage, and oversee the day-to-day operations of clinical trials, ensuring adherence to GCP, regulatory requirements, and company SOPs.
  • Plan and coordinate clinical trial timelines, budgets, and resource allocation to ensure efficient delivery of study milestones.
  • Serve as the primary point of contact for clients, sponsors, and key stakeholders, maintaining strong relationships and ensuring clear communication throughout the project lifecycle.
  • Ensure the successful execution of all operational aspects of clinical trials, including site selection, initiation, monitoring, and closeout.
  • Collaborate with cross-functional teams, including project management, data management, regulatory affairs, and quality assurance, to support clinical trial execution.
  • Supervise, mentor, and develop the clinical operations team, ensuring high performance and professional growth.
  • Monitor and report on study progress, identifying risks and implementing mitigation strategies to resolve issues and meet study objectives.
  • Ensure proper documentation, including trial master files (TMF), regulatory submissions, and patient data.
  • Manage vendor relationships, including CROs, labs, and other external service providers, ensuring high-quality service delivery.
  • Support business development efforts by participating in client proposals and presenting clinical operations capabilities.
Qualifications and Experience:
  • Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree (MSc, PhD, or equivalent) is a plus.
  • Minimum of 5 years of clinical research experience, including at least 2 years in a leadership or management role within a CRO, pharmaceutical, or biotech company.
  • Comprehensive understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements.
  • Strong project management skills with the ability to manage multiple projects simultaneously.
  • Proven experience in managing clinical trials from start-up to closeout across various phases (I-IV).
  • Ability to develop strong client and team relationships while balancing project delivery and business objectives.
  • Familiarity with eTMF systems and other clinical trial management systems is highly desirable.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunity to work in a small, growing CRO where you will have a direct impact on project success.
  • Supportive, collaborative, and flexible work environment.
  • Opportunities for professional development and career advancement.


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