Clinical Trials Manager- Oncology

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Job Description
 

We are seeking a Clinical Trials Manager to support the lung and thoracic area within our oncology pipeline.

Specific Job Responsibilities:

• Coordinating and supervising all aspects of a clinical study.
• Monitors clinical trial sites.
• Assists Clinical Program Manager in overall study management.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Manage CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• May contribute to development of abstracts, presentations, and manuscripts,
• Ensures effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• Assists in determining the activities to support a project’s priorities within functional area.
• Under supervision, may design scientific communications within the company.
• Minimal travel (<10%) may be requested
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• May serve as a resource for others within the company for clinical trials management expertise.
• Under general supervision, is able to examine functional issues from an organizational perspective.
• 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.

Specific Education & Experience Requirements:

• 5+ years of experience and a BS or BA in a relevant scientific discipline required OR
• 3+ years of experience and a MS in a relevant scientific discipline

 

The salary range for this position is: $133,195.00 - $172,370.00. 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:

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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