Clinical Trials Manager

Gilead Sciences

1d • $133,195 - $189,640 • Onsite

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. As a Clinical Trials Manager at Gilead/Kite, you will be responsible for 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. 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. Travel is required.

Requirements

• Bachelor's Degree and 5 Years' Experience OR Masters' Degree and 3 Years' Experience
• 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.
• Travel is required.

Nice To Haves

• 6+ years of experience and an RN (2 or 3 year certificate).

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.
• 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.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans.
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

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