Clinical Trials Manager, Clinical Operations- Oncology

Description

Clinical Trials Manager, Clinical Operations - Oncology (CTM)

We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team.

Specific Responsibilities and Skills for Position :

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Maintains study timelines
• Coordinates review of data listings and preparation of interim / final clinical study reports
• Assists in determining the activities to support a project’s priorities within functional area
• Contributes to development of RFPs and participates in selection of CROs / vendors
• May be asked to train CROs, vendors, investigators and study coordinators on study requirements
• Contributes to development of study budget
• May serve as a resource for others within the company for clinical trials management expertise
• Able to examine functional issues from an organizational perspective
• Participates in the recruiting and hiring process for CPA / CTMA / Sr. CTMA and support their professional development
• May contribute to development of abstracts, presentations and manuscripts
• Under supervision, may design scientific communications within the company
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
• Must have a general, functional expertise to support SOP development and implementation
• Travel may be required

Knowledge :

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

Experience and Skills :

• At least 5+ years of experience and BS / BA in a relevant scientific discipline
• At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferred
• Prior oncology clinical trials experience

The salary range for this position is : $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit :

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

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.