Senior Clinical Trail Management Associate

Kite Pharma • Santa Monica, CA

10d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We are looking for a Senior Clinical Trial Management Associate in our Santa Monica, CA facility. As a Senior Clinical Trail Management Associate, at Gilead you will ...

Requirements

• Master’s and 2+ years of relevant experience OR Bachelor’s and 4+ years of relevant experience OR Associate and 5+ years of relevant experience OR High School Diploma/GED and 6+ years of XXX experience

Nice To Haves

• CCRA or other certification desired
• Excellent verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Develop tools and processes that increase measured efficiencies of the project.
• Anticipate obstacles and proactively develop solutions to achieve project goals.
• General understanding of functional issues and routine project goals from an organizational perspective.

Responsibilities

• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel may be expected.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level