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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical operations, particularly in managing clinical trials within the ophthalmology portfolio, ensuring compliance with protocols, GCP, and regulatory requirements. Proven ability to develop study documents, manage CROs, and lead cross-functional collaboration for successful program delivery.
Highest-signal resume keywords
Clinical Trial ManagementOphthalmology ExperienceGCP ComplianceCRO ManagementStudy Document Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsStudy Budget ManagementEnrollment ProjectionsOperational PlanningTrial Master File MaintenanceProtocol DevelopmentInformed Consent Form AuthoringClinical Study Report WritingSOP DevelopmentRisk Identification
Soft Skills
Interpersonal SkillsAnalytical SkillsProblem-Solving SkillsAdaptabilityTeam Collaboration
Industry Keywords
Clinical TrialsPhI–PhIIIGene TherapyStakeholder CommunicationGlobal Collaboration
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the day-to-day management and oversight of clinical trials within the ophthalmology portfolio to ensure deliverables are met and within budget
- Develop and maintain study timelines, enrollment projections, operational plans, and study budgets
- Oversee and manage CROs and other external vendors
- Contribute to or author study documents, including protocols, informed consent forms, investigator brochures, clinical study reports, and other documents and plans
- Ensure the Trial Master File is set up and maintained appropriately throughout the trial, including periodic reviews
- Ensure studies are executed in accordance with protocols, GCP, company SOPs, and applicable regulatory requirements
- Provide operational input into clinical development plans and portfolio strategy discussions
- Participate in developing clinical operations processes and SOPs
- Establish and maintain collaboration with global cross-functional colleagues to ensure timely, high-quality, and within-budget program delivery
- Keep stakeholders advised on project status and emerging issues
- Identify emerging risks, issues, and opportunities across programs and translate insights into practical actions
- Manage and develop clinical operations personnel as the program advances and the team expands
Requirements
What you’ll need- Minimum of 8-10 years of experience in clinical operations with significant clinical trial experience globally across PhI–PhIII
- Ability to build strong relationships with the sites and CRO
- Ability to deal with ambiguity and work in a dynamic, fast-paced environment and adapt to changes in program or project planning
- Demonstrated self-starter and team player with strong interpersonal skills
- Excellent written and verbal skills
- Strong analytical and problem-solving skills, with strong attention to detail
- Experience in ophthalmology and/or gene therapy preferred
- Candidates need to be legally able to work in the US (US citizen or US work permit)
Benefits
Comp & perks- Opportunity to help develop breakthrough therapies for patients with serious vision-threatening diseases
- Work alongside a passionate, highly experienced team at the forefront of ophthalmology innovation
- Meaningful impact in a growing biotech company
- Collaborative, entrepreneurial culture where science and innovation drive decision-making
