Operations Manager, Clinical Research at PSI CRO AG in remote, REMOTE, United States

Job description

• The Manager Operations is responsible for overseeing the operational conduct of clinical trials at
• contracted medical institutions within a defined country or region in accordance with Milestone One
• contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and
• Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This
• position plays a key role in staff development, process improvement, and continuous operational
• excellence.

Responsibilities

• Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.
• Monitors the progress of budget negotiations and study activation timelines to support timely site readiness.
• Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team.
• Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures.
• Creates a work culture environment that promotes process transparency, accountability, and continuous learning.

Requirements

• Associate degree in life sciences or similiar. Business Management degree or certification is a plus.
• Certifications ICH GCP Training
• Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred.
• Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out.
• Fluent use of English
• Proficiency in MS Office
• Valid category B driver’s license
• Excellent communications skills
• Excellent management skills, experience managing remote staff preferred.
• Effective problem solving and result oriented
• Accountable
• Team leadership skills

Skills

Required

• Fluent use of English
• Proficiency in MS Office
• Excellent communications skills
• Excellent management skills
• Accountable
• Team leadership skills