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Clinical Operations Director
2 months ago
X is a dynamic and growing contract research organization (CRO) based in London, dedicated to providing high-quality clinical research services to pharmaceutical, biotech, and medical device companies. We specialize in delivering innovative solutions to meet our clients' needs and are committed to improving patient outcomes through clinical research excellence.
Key Responsibilities:- Manage clinical trial activities from start to finish, ensuring projects are delivered on time, within scope, and to the highest quality standards.
- 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.
- 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.
- 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.
