Description:
The Director of Clinical Operations will play a pivotal role in overseeing and managing the clinical trial operations for Our Client. This role involves leadership, strategic planning, and execution to ensure the successful implementation of clinical trials, while adhering to industry standards and regulations. The successful candidate will have a deep understanding of clinical research, a track record of leadership in clinical operations, and a passion for bringing life-changing drugs to market.
Key Responsibilities
- Lead and oversee the clinical operations team, ensuring the development, implementation, and execution of clinical trial plans in accordance with company objectives and regulatory requirements.
- Develop and manage clinical trial budgets, timelines, and resource allocation to optimize trial efficiency.
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, to ensure seamless execution of clinical trials.
- Develop and maintain strong relationships with CROs, vendors, and investigative sites to ensure the timely initiation, conduct, and completion of clinical trials.
- Implement best practices and innovative approaches to improve clinical operations processes, quality, and efficiency.
- Monitor and evaluate clinical trial data and performance metrics to identify and mitigate potential risks, ensuring compliance with quality standards.
- Ensure adherence to Good Clinical Practice (GCP) guidelines, relevant regulations, and industry standards.
- Foster a culture of collaboration, innovation, and continuous improvement within the clinical operations team.
- Provide strategic input and contribute to the development of clinical trial protocols and study designs.
- Participate in the selection, evaluation, and management of external partners and vendors.
- Present clinical operations updates and progress reports to executive leadership and stakeholders.
Qualifications
- Bachelor's degree in a relevant field (advanced degree preferred).
- 8+ years of experience in clinical operations within the pharmaceutical or biotech industry.
- Proven experience managing clinical teams and successfully leading complex clinical trials.
- Thorough knowledge of ICH GCP guidelines and relevant regulatory requirements.
- Strong project management skills, including budget and timeline management.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
- Demonstrated ability to identify and implement process improvements.
- Exceptional problem-solving and decision-making capabilities.
- Strong organizational and leadership skills.
- Ability to adapt in a fast-paced and dynamic environment.
- A commitment to ethical conduct, patient safety, and data integrity.