Assistant Director of Clinical Trial Operations

2 months ago

New Haven, United States Coda Search│Staffing Full time

**Position Summary:**


Seeking a dedicated and experienced professional to join our team as the Assistant Director of Clinical Trial Operations. This role is crucial in overseeing and managing the operational aspects of clinical trials within the university’s research community. The Assistant Director will work closely with investigators, research staff, and external partners to ensure the successful execution of clinical trials, maintaining compliance with regulatory requirements and university policies.


**Key Responsibilities:**


- **Operational Leadership:** Provide strategic leadership and direction for the daily operations of clinical trials. Oversee the planning, implementation, and management of multiple clinical trials to ensure they are completed on time, within budget, and according to all regulatory and ethical standards.


- **Compliance and Quality Assurance:** Ensure all clinical trials adhere to FDA, GCP, IRB, and other regulatory guidelines. Develop and implement quality assurance processes to monitor and maintain compliance throughout the trial lifecycle.


- **Team Management:** Supervise and mentor a team of clinical trial coordinators and support staff. Foster a collaborative and high-performance work environment, providing training and development opportunities to enhance team capabilities.


- **Budget and Resource Management:** Develop and manage clinical trial budgets. Oversee the allocation of resources, including staffing, equipment, and materials, to ensure efficient and effective trial operations.


- **Stakeholder Collaboration:** Act as a liaison between investigators, research staff, university departments, and external partners. Facilitate communication and collaboration to support the successful conduct of clinical trials.


- **Data Management and Reporting:** Oversee the collection, management, and analysis of trial data. Ensure accurate and timely reporting of trial progress, outcomes, and any adverse events to relevant stakeholders.


- **Process Improvement:** Identify opportunities for process improvements in clinical trial operations. Develop and implement initiatives to enhance efficiency, reduce costs, and improve the quality of trial outcomes.


**Qualifications:**


- **Education:** Bachelor’s degree in a relevant field required. Advanced degree (Master’s, PhD, or equivalent) in clinical research, healthcare, or a related discipline preferred.


- **Experience:** Minimum of 5-7 years of experience in clinical trial operations (preferably oncology), including experience in a leadership or management role. Demonstrated expertise in managing complex clinical trials and leading cross-functional teams.


- **Skills:**

- Strong knowledge of FDA, GCP, IRB, and other regulatory requirements.

- Excellent organizational and project management skills.

- Superior communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.

- Proficiency in clinical trial management systems and related software.

- Ability to analyze and interpret complex data and provide actionable insights.


- **Attributes:**

- Detail-oriented with a commitment to maintaining high standards of quality and compliance.

- Problem-solving mindset with the ability to adapt to changing priorities.

- Strong leadership capabilities with a focus on team development and mentorship.

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