Title: Director, Clinical Trials Operations
Location: Irvine, CA
 
Job Summary:
Responsible for supervision and management of the Clinical Research staff in order to successfully move multiple projects through the clinical research process in a timely and quality manner and in accordance with FDA and ICH guidelines. This includes having well-established clinical policies and procedures in order to increase the efficiency of clinical trial management.

Working in a project team environment, the director will ensure that resources are available, either internally or externally.

Duties & Responsibilities:

• Evaluates and determines specific resources needed in the conduct of clinical trials and determines current sourcing strategy(ies)
• Defines project- or function- specific sourcing strategies with input from project team members or functional representatives, as appropriate
• Works cross functionally with Clinical Directors on the outsourcing strategy and contracting process for trials.
• Provides outsourcing services in support of Project Teams and functional groups, to include the Request for Proposal (RFP) process, service provider identification, selection, bid presentation, bid analysis, vendor assessment visit, contract development, change orders and issue management
• Participates in negotiations with vendors
• Measures performance of vendors with respect to quality of work, cost, timelines and other related parameters
• Implements the procurement strategy and policies within teams and functions
• Ensures appropriate risk evaluation and mitigation while meeting business needs
• Facilitates sourcing and contracting issue escalation and resolution
• Guides project teams in identification and resolution of outsourcing issues
• With the Clinical Directors provides input and finds solutions for teams for financial questions related to preferred vendor contract management
• Identify training needs related to service provider management and outsourcing process, including how to work most effectively with outsourcing service providers
• Implements and maintains a process improvement process for projects that enhance and streamline outsourcing and contracting processes, systems, tools and other resources
• Ensures training is provided to teams or functions on sourcing and contracting processes
• Ensures that SOPs are current and complete
• Ensures that all personnel have appropriate ongoing training
• Responsible for creating clinical policies and procedures to provide strong and efficient clinical trial management, including working with other departments for shared responsibilities
• Responsible for determining staffing needs for management of clinical trials, including personnel requisitions, and hiring and assigning of staff, contract staff, and CRO support
• Responsible for coaching, mentoring, supervising, developing/training staff who are involved in Clinical Operations
• Facilitates relationship between clinical operations and other internal stakeholders of project teams
• Works closely with the Clinical Directors to verify all clinical studies are completed within budget and appropriate funds are available for conduct of the studies
• Requires approximately 30% travel

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