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Clinical Program Manager
Gilead Sciences. Oversee worldwide execution of Phase I–IV clinical trials across Gilead therapeutic areas .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing Phase I–IV clinical trials, ensuring compliance with regulatory guidelines, and overseeing project budgets and timelines. Proven ability to lead cross-functional teams, develop strategic plans, and effectively communicate project status while managing relationships with CROs and vendors.
Highest-signal resume keywords
Clinical Trial ManagementCross-Functional LeadershipRegulatory ComplianceFinancial OversightStudy Management Best Practices
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 DocumentationSOP DevelopmentRFP DevelopmentFull-Cycle Study ManagementKnowledge of FDA RegulationsKnowledge of ICH GuidelinesKnowledge of GCPTherapeutic Area ExpertiseProject ManagementRisk Assessment
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsCoaching and MentoringChange Management
Tools & Technologies
Study Management ToolsProject Tracking Tools
Industry Keywords
Clinical TrialsLife SciencesCRO ManagementRegulatory GuidelinesQuality Standards
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee worldwide execution of Phase I–IV clinical trials across Gilead therapeutic areas
- Ensure clinical trials comply with SOPs, company policies, regulatory guidelines, and quality and timeliness standards
- Manage successful execution of studies and multiple studies within programs, including financial responsibility
- Assess and deploy study resources to support the One Ops workforce
- Provide ongoing financial oversight of assigned clinical trials and programs
- Provide input into therapeutic-area and functional-area strategic and operational plans
- Guide and oversee clinical trial management within program budgets and timelines
- Lead cross-functional Study Management Teams and influence stakeholders
- Manage and revise project timelines and budgets with cross-functional teams
- Communicate project status and issues, escalate issues, and ensure team goals are met
- Contribute to study documentation, including protocols
- Select, manage, and oversee CROs and vendors, including RFP development
- Identify obstacles and implement solutions, risk assessments, and mitigation strategies
- Resolve issues under national and international regulations and guidelines
- Track, oversee, and communicate program status using available tools
- Lead or participate in departmental and interdepartmental strategic initiatives
- Develop, implement, and train on SOPs
- Ensure affiliate Clinical Operations activities meet local regulations and usual practice
- Ensure team work complies with established practices, policies, processes, and regulatory requirements
- Hire, develop, and retain diverse talent; set expectations and coach direct reports on performance and career development
Requirements
What you’ll need- BA / BS / RN with 8 or more years’ relevant clinical or related experience in life sciences, or MA / MS / PharmD / PhD with 6 or more years’ relevant clinical or related experience in life sciences
- Minimum of 4 years’ cross-functional study management or related leadership experience in life sciences
- Multiple years’ experience managing study or project teams
- Advanced knowledge of one or more disease or therapeutic areas
- Experience developing RFPs and selecting, overseeing, and managing CROs or other vendors
- Ability to start up, manage, and close out clinical studies
- Experience authoring clinical study and regulatory documentation and SOPs
- Complete knowledge of full-cycle study management
- Advanced knowledge of study management best practices and tools
- Thorough knowledge of FDA, EMA, national regulations, ICH guidelines, and GCP
- Ability to lead and influence programs, projects, and initiatives
- Strong interpersonal, communication, and organizational skills
- Ability to work successfully in a team-oriented, highly matrixed environment
- Effectiveness coaching, guiding, directing, and managing the performance of others
- Effectiveness proactively managing change
- Ability to travel as required
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance