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Clinical Operations Director
2 months ago
We are seeking a highly skilled Clinical Operations Director to join our team at Albion Rye Associates Limited. As a key member of our clinical operations team, you will be responsible for leading and managing the day-to-day operations of clinical trials, ensuring adherence to GCP, regulatory requirements, and company SOPs.
Key Responsibilities:- Lead and manage clinical trial operations, including site selection, initiation, monitoring, and closeout.
- Plan and coordinate clinical trial timelines, budgets, and resource allocation to ensure efficient delivery of study milestones.
- Develop and maintain strong relationships with clients, sponsors, and key stakeholders, ensuring clear communication throughout the project lifecycle.
- Collaborate with cross-functional teams to support clinical trial execution, including project management, data management, regulatory affairs, and quality assurance.
- 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.
- 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.
- Competitive salary and benefits package.
- Opportunity to work in a dynamic and 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.
