Clinical Operations Manager

Serve as a dedicated clinical operations subject matter expert within a cross-functional team Drive core operational milestones from study design through study closeout Author and establish clinical protocols, informed consent forms, and participant-facing materials Implement integrated quality risk management and study monitoring plans alongside clinical SOPs Manage clinical site operations, protocol deviations, adverse event evaluations, and IRB reporting Oversee electronic Trial Master Files to maintain GCP compliance, regulatory adherence, and audit readiness Manage research timelines from inception through publication Provide project management support for evidentiary claim development projects across Research, EvGen, and Clinical Quality teams Requirements Bachelor's degree in a life sciences, healthcare, or technical field, or equivalent practical experience 4+ years of direct experience in clinical operations, clinical trial management, or a related operational role within healthcare or biotechnology Direct experience drafting clinical study documentation, including protocols and informed consent forms Experience managing electronic Trial Master File systems Strong subject matter expertise working inside cross-functional project or product teams Deep familiarity with GCP compliance, regulatory submission considerations, and clinical SOP development Excellent communication skills for providing clear clinical operational guidance to cross-functional stakeholders Strong organizational skills supporting evidentiary claim development aligned with commercial needs Project management certification preferred Experience with JIRA preferred Must not require employer-sponsored work authorization now or in the future for employment in the United States Core Competencies Demonstrates expertise in clinical operations, including drafting clinical study documentation and managing electronic Trial Master Files to ensure GCP compliance and regulatory adherence. Proven ability to drive project management initiatives and provide operational guidance within cross-functional teams. Highest-signal resume keywords Clinical Operations Management Clinical Trial Management GCP Compliance Project Management Certification Electronic Trial Master File Systems ATS Optimization Keywords Hard Skills Clinical Protocol Development Informed Consent Form Drafting Quality Risk Management Study Monitoring Plans Protocol Deviation Management Adverse Event Evaluation IRB Reporting Research Timeline Management Evidentiary Claim Development Clinical SOP Development Soft Skills Excellent Communication Skills Strong Organizational Skills Certifications & Qualifications Project Management Certification Industry Keywords Life Sciences Healthcare Biotechnology Regulatory Submission Cross-Functional Teams Tools & Technologies JIRA