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Clinical Trials Manager
Gilead Sciences. Drive end-to-end operational delivery of Phase II and III oncology trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Phase II and III oncology trials, including oversight of clinical study protocols, regulatory compliance, and CRO/vendor management. Proficient in maintaining study timelines, budgets, and documentation while ensuring effective communication and collaboration among stakeholders.
Highest-signal resume keywords
Oncology ExperienceCRO ManagementClinical Trial OversightFDA Regulations KnowledgeGCP Compliance
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 Study ManagementProtocol DevelopmentBudget DevelopmentData Discrepancy ResolutionSOP Development
Soft Skills
TeamworkCommunicationDecision-MakingOrganizational Skills
Industry Keywords
Phase II TrialsPhase III TrialsCROPharmaBiotechEMEA RegulationsICH GuidelinesGCPs
About the role
Key responsibilities & impact- Drive end-to-end operational delivery of Phase II and III oncology trials
- Coordinate and supervise all aspects of clinical studies
- Assist the Clinical Program Manager with overall study management
- Provide input into study protocols, investigator brochures, case report forms, informed consents, final study reports, study plans, and presentations
- Maintain study timelines, documentation, and communications
- Contribute to study budgets and RFP development
- Participate in CRO/vendor selection
- Manage CROs, vendors, or functional service providers as assigned
- Oversee site evaluation, initiation, close-out, and monitoring visits
- Provide oversight of study sites/regions and review regulatory documents for compliance
- Ensure effectiveness of site budget and contract processes
- Train CROs, vendors, investigators, and study coordinators on study requirements as needed
- Coordinate data listings and interim/final clinical study reports and appendices
- Resolve data discrepancies
- Develop tools and processes to optimize project efficiency and effectiveness
- Serve as a resource for clinical trials management expertise
- Examine functional issues from an organizational perspective under general supervision
Requirements
What you’ll need- Prior Oncology experience required
- Prior CRO/Pharma/Biotech experience required
- 5+ years with BS/BA in a relevant scientific discipline
- 3+ years with MS/MA in a relevant scientific discipline
- Travel required
- Excellent teamwork, communication, decision-making and organizational skills
- Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials is desirable
- Ability to understand, interpret, and explain protocol requirements
- Ability to prioritize multiple tasks
- General functional expertise to support SOP development and implementation
Benefits
Comp & perks- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives eligibility
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Reasonable accommodation during the job application process