Clinical Program Manager - Clinical Operations

Arbeitsbeschreibung

We are seeking a highly motivated individual to join us as a Clinical Program Manager, Clinical Operations.  You will manage multiple study teams across a program and ensure consistency and quality in all aspects of Kite clinical trials.  The candidate must have prior experience managing direct reports and be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Senior Director of US Clinical Operations.

Responsibilities include but are not limited to:

• Accountable for all operational aspects of clinical trials within the assigned program(s)
• Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Examine functional issues from a broader organizational perspective and develop a strategy to implement with a cross-functional team
• Provides program level oversight to vendors, including CRO, central lab, and imaging.
• Proactively identifies potential issues/risks across the program and recommends/implements solutions.
• Participates in the selection, training and evaluation of clinical trial managers and clinical trial management associates to ensure the efficient operation of the function.
• Leads the development, review and implementation of departmental SOPs and processes.
• Attends and presents at cross-functional meetings as needed to represent Clinical Operations and program level items
• Provides mentorship and career development to direct reports.
• Provides leadership to the clinical operations team working on the assigned program.
• Other duties as assigned.

Basic Qualifications:

• BA/BS degree in nursing, science or health related field w/8+ years clinical trial experience
• MS/MS degree in nursing, science or health related field w/6+ years clinical trial experience

Preferred Qualifications:

• At least 7 years of related clinical trial management experience. Knowledge of oncology, transplant patient care, and apheresis collection a plus.
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Proficient in developing trial plans and implementing operational changes across multiple studies
• Highly developed leadership skills to successfully lead multiple direct reports
• Must display strong analytical and problem solving skills at a program level and collaborate with colleagues to generate solutions
• Strong communication and influence skills and ability to create a clear sense of direction
• Ability to deal with time demands, incomplete information or unexpected events
• Outstanding organizational skills with the ability to multi-task and prioritize
• Attention to detail required
• Must be willing to travel at least 25% (possibly more)
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities