What are the responsibilities and job description for the USA - Associate Director Clinical Operations Program Leader position at The Fountain Group?
We are currently seeking a --------GCP - Clinical quality Program Leader for a prominent client of ours. This position is located in --Cambridge, MA. Details for the position are as follows:
Job Title: Associate Director, Clinical Program Quality
Pay: $166 - $172.41 per hour
Duration:1 yr
OBJECTIVES:
Job Title: Associate Director, Clinical Program Quality
Pay: $166 - $172.41 per hour
Duration:1 yr
OBJECTIVES:
- Provides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
- Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
- With the guidance of Head of Clinical Program Quality, TAU, defines and implements a risk-based program audit strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate and timely investigations and mitigations are in place.
- Leads the clinical pre-approval inspection (PAI) readiness programs, the management of the inspection and the response and follow-up activities. Ensures that any inspection risks are well-communicated and mitigated. These inspections include both sponsor and investigator sites.
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
- Assume complex assignments on issues or studies where there is no precedent
- Mentor and provide support to Manager level CPQ personnel, as needed
- Represent CPQ in program-specific meetings and global CPQ team assigned
- GCP Quality Assurance registration/certification preferred
Salary : $166 - $172