Clinical Operations Manager

PSI CRO AG

Clinical Operations Manager overseeing and developing Clinical Research Associates at PSI, a leading CRO with 30 years in the industry. Responsible for operational excellence and successful clinical trial delivery.

Posted 7/7/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research management, including team leadership, resource allocation, and quality control. Proficient in regulatory compliance and operational efficiency within clinical trials.

Highest-signal resume keywords

Clinical Research ManagementTeam LeadershipResource PlanningICH-GCP KnowledgePerformance Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperiencePerformance ManagementResource AllocationQuality ControlRegulatory ComplianceAudit SupportFeasibility AssessmentClinical Trial OperationsEmployee DevelopmentWorkload Management

Soft Skills

LeadershipCoachingCommunicationOrganizational SkillsProblem-Solving

Tools & Technologies

Microsoft OfficeClinical Research Systems

Industry Keywords

Clinical Research AssociateCROSponsorLife SciencesRegulatory Inspections

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Line manage, coach, mentor, and develop Clinical Research Associates across multiple experience levels.
Manage hiring, onboarding, performance management, and professional development activities.
Oversee resource allocation, workload planning, and utilization across clinical trials.
Collaborate with Project Managers and cross-functional teams to ensure successful study delivery.
Monitor staff performance and support operational efficiency through established departmental metrics.
Implement departmental quality controls and contribute to the development and continuous improvement of quality systems and processes.
Prepare for and participate in internal audits, sponsor audits, and regulatory inspections.
Support trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites.
Participate in feasibility assessments for new and ongoing studies.
Support business development activities, including client meetings, networking events, and operational discussions, as needed.

Requirements

What you’ll need

MD, PharmD, or a university degree in Life Sciences, or an equivalent combination of education, training, and experience.
Minimum of 5 years of clinical research industry experience, including demonstrated team management or people leadership experience.
Previous experience working independently as an onsite Clinical Research Associate (CRA) is required.
Previous experience managing or mentoring clinical research professionals in a CRO, sponsor, or related clinical research environment.
Strong leadership, coaching, and employee development skills.
Experience with resource planning, workload management, and performance management.
Working knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial operations.
Experience supporting audits, inspections, and quality initiatives is preferred.
Excellent communication, organizational, and problem-solving skills.
Proficiency with Microsoft Office applications and clinical research systems.
Advanced English proficiency (written and spoken).
Strong interpersonal skills with the ability to build trust, foster collaboration, and develop high-performing teams.

Benefits

Comp & perks

All your information will be kept confidential according to EEO guidelines