Description
Clinical Operations Manager, North America
The Clinical Operations Manager is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates (CRA)/(cCRA)) and other Clinical Operations Support personnel) overseeing their performance and training, ensuring adequate monitoring and support team resources, allocating resources to projects, identifying quality issues related to Clinical Operations activities and establishing action plans to address them.
This role will be perfect for you if :
- You thrive in leading and developing teams, bringing a strong ability to coach, mentor, and drive performance while fostering a collaborative, accountable, and high-quality Clinical Operations environment.
- You are highly operational and quality-driven, with solid experience in clinical monitoring and a proven ability to manage resources, track metrics, resolve issues proactively, and ensure compliance with SOPs, GCP, and regulatory requirements.
- You embrace innovation and continuous improvement, demonstrating agility in fast-paced environments, leveraging technology and AI tools to optimize processes, and confidently driving change across cross-functional teams.
RESPONSIBILITIES
More specifically, the Senior Clinical Operations Manager must:
- Ensure that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
- Oversee the performance of their direct reports, ensuring they are meeting performance objectives and taking appropriate remedial actions as required. Implement professional development and performance evaluations.
- Support the training and development of Clinical Operations personnel within their remit, providing coaching and mentoring. Ensure team members’ consistent use of study tools and training materials.
- Assist in developing and delivering training for Clinical Operations personnel.
- Track Clinical Operations metrics and monitor adherence to targets (e.g., number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training.)
- Ensure monitoring expenses are compliant with policy and aligned with established guidelines.
- Perform Quality Assessment Visits (QAV) with CRAs.
- Identify quality issues related to Clinical Operations activities through project meetings, site and team communications, site visit reports and follow-up letters, QAVs, and quality assurance audit findings. Summarize findings and establish action plans to bring corr