Sr Clinical Trials Manager

Responsibilities

• Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership as applicable.
• Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
• Ensure studies are delivered on time, within budget, and in alignment with quality, protocol, SOP, and regulatory requirements.
• Identify study risks and proactively drive mitigation and issue-resolution strategies.
• Lead CRO and vendor selection, oversight, deliverable management, and relationship management as applicable.
• Partner with cross-functional stakeholders to align on study objectives, priorities, timelines, and deliverables.
• Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators.
• Mentor and support the development of less experienced colleagues.
• Contribute to process improvement, standardization, operational excellence, and departmental initiatives.

Requirements

• BA/BS with 6+ years of relevant clinical or related life sciences experience; or MA/MS with 4+ years of relevant clinical or related life sciences experience.
• Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.
• Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
• Experience leading clinical studies and cross-functional project teams.
• Demonstrated ability to lead teams, coach, and mentor less experienced colleagues.
• Clear, concise communication skills and strong interpersonal effectiveness.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• Strong knowledge of full-cycle study management, from start-up through close-out.
• Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
• Ability to travel as needed.
• People Leader Accountabilities:
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
• For additional benefits informati

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Clinical Operations leads the global execution of Phase I-IV clinical trials across therapeutic areas, ensuring studies are conducted in compliance with SOPs, company policies, and regulatory requirements while delivering timely, high-quality data to support registration and commercialization. The Senior Clinical Trials Manager leads studies within a program, provides direction to Clinical Operations team members, and is accountable for execution against timelines, budgets, and quality standards. This role develops study operational strategies and may contribute to cross-functional or organizational initiatives.

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