Director Clinical Operations (Processes, Training, Systems)

Confidential Company  •  Brisbane, CA

15+ years experience  • 

$180K - $225K
Posted on 05/24/18 by Lindsey Summers
Confidential Company
Brisbane, CA
15+ years experience
$180K - $225K
Posted on 05/24/18 Lindsey Summers

Director Clinical Operations (Processes, Training, Systems)

Brisbane, CA

Permanent or Contract



?        Lead the creation, deployment, and management of Clinical Operations systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness

?        Oversee development/deployment of Clinical Operation Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP guidelines and company policies to ensure inspection readiness

?        Represent Clinical Operations on Inspection Readiness progress and activities

?        Partners with CQA to oversee GCP regulatory authority inspections on behalf of Clinical Operations

?        Provide oversight/strategic guidance for key clinical systems, such as eTMF and document management

?        Participate as a member of the Clinical Operations Leadership Team in the development and execution of organizational initiatives, goals, and strategies

?        Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancements, and training

?        Management of any additional future Clinical Systems, Solutions, and Compliance staff or consultants

?        Provide input/rationale for department budget and maintaining control of functional expenditures against department budget as they relate to this role

?        Develop and present strategic and operational plans to senior management




?        BachelordegreeREQUIRED; advanced degree highly preferred

?        15+ years of experience in Clinical Research, with a focus on biotech and/or pharmaceutical Clinical Operations

?        Experience in GCP regulatory authority inspections, process development and improvement, training and development, development of a clinical compliance function, and clinical systems

?        Experience develop/lead a clinical risk management function and the ability to demonstrate an understanding of a clinical quality management system

?        Previous experience in leading a function or business unit

?        Direct experience with regulatory authority inspections, including both FDA and EMA Inspections

?        Previous experience focusing on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors

?        Open to domestic/international ~ 20%

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