Assoc Dir Clinical Dev Operations Excellence & Training in Basking Ridge, New Jersey at DSI

Date Posted: 6/5/2019

Job Snapshot

Job Description

Job Summary:
The individual in this position will be responsible to drive establishment of a clinical quality training curricula that supports senior leadership clinical operations competencies and risks identified across resources, processes and technologies used in clinical trials. The person in this position must have strong leadership and influencing skills and at least 7 - 10 years of experience with organizational transformation projects/clinical training. This position reports directly to the Director, Process Excellence & Risk Management.

Responsibilities:
  • Develop and manage a plan for establishing a competency model with the focus on Project Management, Vendor Management and Stakeholder management. This model will enable effective management of people, processes and risks and enables access to knowledge that may prompt improvements
  • Create and implement a training plan with the focus on CDO Onboarding Project, Vendor and Stakeholder management and any other process improvement initiative within Clinical Development Operations
  • Ensure the Leadership team and OPLs are aligned with the competencies/training plan and develop individual plans for their study managers
  • Lead cross-functional groups of colleagues in assessing risks to quality and developing action plans and work with cross-functional leadership to develop, prioritize and implement improvements needed to reduce/mitigate risk
  • Establish a capability for analyzing process improvements / change needed and determining highest priority areas for support, resulting in best-fit resource utilization
  • Establish and manage metrics related to risks that facilitate continuous improvement; Design and implement a measurement system that supports performance assessment used to identify process improvements
  • Establish support for cross-functional colleagues in the development of responses for internal system audits and regulatory inspections that address identification of actual root cause and improvements needed
  • Support development of a strategy map resulting in greater alignment between initiatives and strategy
Qualifications:
Education
7 -10 years relevant experience is required with a Bachelor’s degree; 5 years with Master’s degree; 2 years with a Doctorate degree
Experience
Minimum 10 years leading or managing transformational improvement project and implementing training in the pharmaceutical or biotech industry