Clinical Trials Manager, Oncology

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 is responsible for the worldwide execution of clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines, to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

Clinical Trials Manager, Clinical Operations - Oncology (CTM)

We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.  This role will be responsible for managing a global clinical Phase 2 Master Protocol Platform Study.  The CTM works cross-functionally with study teams, investigators, site staff, and vendors to ensure trial objectives are met on time.

Specific Responsibilities and Skills for Position:

• Leads the trial team to execute and deliver the clinical trial in accordance with the clinical development plan/strategy, budget, and timeline. 

• Must be able to understand, interpret and explain protocol requirements to others.

• Develops, manages, and approves operational plans, charters, study tools, training materials, and manuals to support trial execution in compliance with regulatory and internal standards and processes. 

• Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking.

• Engages in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively.

• Ensures compliance with monitoring and monitoring oversight plans by identifying and escalating trends as identified during monitoring report review.

• Coordinates timelines and review of data listings and preparation/execution of Safety Review Team meetings and interim/final clinical study reports.

• Oversees assessing CRO(s) and other clinical vendor key performance indicators (KPIs) and manages escalation for internal and external stakeholders.

• Evaluates site and study performance metrics against agreed upon site budget, deliverables, and timelines.

• Work closely with Clinical Supply Chain Management ensures on-time delivery of clinical supplies, study drug, etc., throughout the project lifecycle; including label development.

• Oversees the identification and selection of investigative sites. 

• Collaborates with Regulatory to prepare global health authority submission packages, when applicable.

• Participates in activities related to development of clinical systems such as EDC and IRT systems, user acceptance testing, and authoring system requirements. 

• Tracks and communicate program/study process to Program Lead/Associate Director and Senior Management with the ability to create and update detailed dashboards and trackers.

Minimum Education & Experience:

• Bachelor's Degree and Five Years Experience; OR

• Masters' Degree and Three Years Experience

• Ability to manage any component of full cycle study management, from start-up to close-out.

• Excellent teamwork, communication, decision-making and organizational skills are required.

• Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.

• Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.

• Working knowledge and experience with Word, PowerPoint, and Excel.

Preferred Qualifications:

• Knowledge of Master Protocol Platform Study design

• Global clinical trial experience in Oncology across multiple countries/regions

• Working knowledge of MSProject

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.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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