Clinical Operations Lead

About the role

PSI, a Contract Research Organization with more than 30 years of experience, is looking for a Clinical Operations Lead to join its management team and help lead and develop the Clinical Operations team in the Latin America region. The role leads and mentors a high-performing team while ensuring efficient resource use, operational excellence and the successful delivery of clinical trials.

Key responsibilities

• Line manage, coach, mentor and develop Clinical Operations staff across multiple experience levels.
• Supervise and conduct training of Monitors, and mentor them.
• Plan and carry out supervised monitoring visits for training, authorization and ongoing assessment purposes.
• Support the professional development of Monitors and contribute to their performance appraisals.
• Support Clinical Operations Managers with resource allocation and staff utilization.
• Perform other Clinical Operations supervisory tasks.

Required profile

• MD, PharmD or a university degree in Life Sciences.
• Previous clinical research industry experience.
• At least 4 years of independent work as an onsite Clinical Research Associate (CRA).
• Experience managing or mentoring clinical research professionals in a CRO, sponsor or related clinical research environment.
• Experience with Oncology or IBD is a plus.
• Advanced written and spoken English.

Required skills

• Working knowledge of ICH-GCP, applicable regulatory requirements and clinical trial operations.
• Resource planning, workload management and performance management.
• Experience supporting audits, inspections and quality initiatives is preferred.
• Proficiency with Microsoft Office and clinical research systems.
• Leadership, coaching and strong communication and problem-solving skills.