Clinical Trials Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $133.2k - $172.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $3.5M Post-IPO Debt - Gilead Sciences on 2024-11

Biotechnology • Pharmaceuticals

Gilead Sciences is a global biopharmaceutical company focused on researching, developing, and commercializing medicines primarily in virology, oncology, and inflammation. The company advances transformative therapies, runs extensive clinical programs and research collaborations, and supports access, global health, and community funding initiatives. Gilead also emphasizes corporate responsibility, sustainability, and inclusion while maintaining a broad pipeline of therapies and patient access programs.

📋 Description

• 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 • Travel is required

🎯 Requirements

• 6+ years of experience • BS or BA in a relevant scientific discipline • RN (2 or 3 year certificate) • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials • Must be able to generally understand, interpret, and explain protocol requirements to others • Must be able to prioritize multiple tasks • Excellent teamwork, communication, decision-making and organizational skills

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives (eligibility may vary based on role) • Paid time off • Company-sponsored medical, dental, vision, and life insurance plans