Clinical Trials Manager- Late Phase Oncology (Office-Based)

About the role

This role will be based out of our Foster City, California or Parsippany, NJ location.

Responsibilities

• Coordinating and supervising all aspects of clinical study.
• Assists Clinical Program Manager in the overall study management.
• Provide input into study protocols, investigator brochures, case report forms, and informed consents, final study reports, oversee/author study plans, and presentations.
• Maintains study timelines, including documentation and communications.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• May manage CROs/vendors or functional service providers.
• May serve as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits.
• Oversees study sites/region and review routine regulatory documents to ensure that CROs /vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• Ensures effectiveness of site budget/contract process.
• Coordinates review of data listings and preparation of interim/final clinical study reports and appendices, including resolving any data discrepancies.
• Assists in determining the activities to support a project’s priorities within functional area.
• Develop tools and processes that optimize project efficiencies and effectiveness.

Requirements

Prior Oncology Experience And Prior CRO/Pharma/Biotech Experience Is Required.

Qualifications

• 5+ Years with BS/BA in a relevant scientific discipline.
• 3+ Years with MS/MA in a relevant scientific discipline.

Skills

Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.

Benefits

• Bay Area: $146,540.00 - $189,640.00.
• Other US Locations: $133,195.00 - $172,370.00.

Pay

The salary range for this position is:

• Bay Area: $146,540.00 - $189,640.00.
• Other US Locations: $133,195.00 - $172,370.00.

Schedule

Travel is required.