Clinical Trials Manager- Oncology

Clinical Trials Manager – Oncology

United States – Remote, United States - California - Foster City Clinical Development & Clinical Operations Regular

We are seeking a Clinical Trials Manager to sit at either our Foster City campus or remotely within the US.

• 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.
• 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.

• 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 general functional expertise to support SOP development and implementation.

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