Sr Clinical Trials Manager

We’re here for one reason and one reason only – to cure cancer. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Requirements

• Provides guidance and daily oversight for the successful management of all aspects of international clinical trials
• Coaches members of a work team and ensures adherence to established guidelines
• Provides input to program budget and timelines to ensure successful management of all aspects of international clinical trials
• Anticipates obstacles and client difficulties and implements solutions to achieve project goals
• Assists CPM in revising project timelines/budgets as necessary
• Works with management on departmental issues, providing input to clinical operations strategies and work plans
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Contributes to development of abstracts, presentations and manuscripts
• Participate in the recruiting and hiring process for CPA/CRAs and support their professional development
• Participate in training of CPAs and CRAs
• Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements
• Excellent interpersonal skills and demonstrated ability to lead is required.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Travel is required.

Benefits

• company-sponsored medical
• dental
• vision
• life insurance plans
• paid time off
• discretionary annual bonus
• discretionary stock-based long-term incentives
• benefits package