Description:
We are seeking a highly experienced and motivated individual to join our clients team as Senior Director of Clinical Operations. The successful candidate will be responsible for overseeing all aspects of clinical operations, ensuring the successful planning, execution, and completion of clinical trials in accordance with regulatory requirements and company standards.
Key Responsibilities:
- Provide strategic leadership and direction for the clinical operations team, including project management, clinical monitoring, site management, and clinical trial logistics.
- Develop and implement efficient and effective processes and procedures to optimize clinical trial conduct and ensure timely delivery of high-quality results.
- Collaborate with cross-functional teams, including project management, data management, biostatistics, and medical affairs, to ensure seamless execution of clinical trials.
- Manage relationships with key stakeholders, including investigational sites, vendors, and sponsors, to foster productive partnerships and ensure alignment with project goals.
- Monitor and analyze key performance metrics to identify areas for improvement and drive operational excellence.
- Stay abreast of industry trends, regulatory requirements, and best practices to inform decision-making and drive continuous improvement.
Qualifications:
- Bachelor's degree in life sciences or related field required; advanced degree (e.g., MD, PhD) preferred.
- Minimum of 10 years of experience in clinical operations within the CRO industry, with at least 5 years in a leadership role.
- Demonstrated track record of successfully managing complex clinical trials across multiple phases and therapeutic areas.
- Strong understanding of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
- Excellent leadership, communication, and interpersonal skills, with the ability to inspire and motivate cross-functional teams.
- Proven ability to develop and implement strategic initiatives to drive operational excellence and achieve business objectives.
- Ability to thrive in a fast-paced, dynamic environment and effectively prioritize and manage multiple competing priorities.