Summary
The Associate Director/Director, Clinical Operations, will lead and oversee the planning, execution, and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. This role is pivotal in driving operational excellence across multiple clinical programs, coordinating cross-functional teams, and optimizing resource allocation to meet project timelines and objectives. The person will serve as a strategic partner to senior leadership, providing insights and recommendations to enhance clinical development strategies and improve patient outcomes. They will also be responsible for fostering a culture of continuous improvement, quality assurance, and adherence to Good Clinical Practice (GCP) guidelines. Ultimately, this position ensures that clinical operations contribute effectively to the successful development and approval of new therapies within the United States and potentially global markets. This position will ideally be onsite in Durham, NC (negotiable) and the role level will be commiserate on candidate's experience.
Responsibilities
- Lead the design, implementation, and management of clinical trial operations from study start-up through close-out.
- Provide primary oversight for the CRO, ensuring that CRO activities are executed per study timelines. Maintain frequent and meaningful contact with the CRO to assess performance and provide oversight and guidance as needed.
- Collaborate with cross-functional departments such as Regulatory Affairs, Data Management, and Clinical Development to ensure alignment and compliance.
- Ensure adherence to all regulatory requirements, company policies, and industry standards including FDA regulations and ICH-GCP guidelines.
- Identify and mitigate operational risks, implementing corrective actions as necessary to maintain study integrity and patient safety.
- Drive process improvements and implement best practices to enhance clinical trial efficiency and data quality.
- Contribute to review of other study documents such as protocols/amendments, eCRFs, clinical study reports, IBs, DSURs, conference presentations, publications, etc.
- In coordination with the cross-functional team, participate in the RFP process and ultimately select CROs and other vendors for clinical trials.
- Participate in the selection of investigational sites with input from relevant stakeholders. Lead the study and site feasibility process in association with the CRO. Assess site and investigator performance and enrollment on a regular basis.
- Develop and oversee clinical operations budgets, timelines, and resource plans to ensure project milestones are met.
- Work closely with Clinical team members to ensure investigational product needs for clinical studies are available and managed appropriately.
- Partner closely with internal functional areas to operationalize the procurement and analysis of biological samples for the study, including contributing to lab manuals, identifying vendors for lab kitting and sample management, and providing regular training and feedback to sites regarding completeness and quality of sample collection.
- Oversee the creation and maintenance of all trial files, including the trial master file. Work with quality assurance to ensure inspection readiness of sites and implement risk-based quality management of the clinical study.
- Mentor clinical operations team members to promote professional growth and high performance.
Qualifications and skills
- Bachelor's or Masters degree in science or health care with a minimum of10+years of Clinical Operations experience, including at least 8 years in direct management of clinical trials.
- Knowledge of clinical drug development, with experience in Phases I-III, CRO/vendor oversight, global clinical trials, and budget/timeline management.
- Thorough understanding of ICH GCP and FDA guidelines.
- Strong interpersonal skills with demonstrated ability to effectively work with internal cross-functional as well as external groups.
- Good communication and interpersonal skills and ability to work with cross-functional teams.
- Self-starter with an entrepreneurial spirit and a good team player.
Employee Benefits
- Competitive salary and health benefits, 401k.
- Opportunities for training and career advancement.
- Collaborative and inclusive work environment.
- Access to cutting-edge research and technology.
