Associate Director

Position : Associate Director Clinical Operations Program Leader

Location : Cambridge, MA (Hybrid Onsite - 8x a month in office)

Duration : 12+ Months

OBJECTIVES :

Focus for this role is ONCOLOGY.

• Provides quality assurance oversight of the global clinical research programs in Oncology Business Unit (OBU) 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.

ACCOUNTABILITIES :

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

LICENSES / CERTIFICATIONS :

PHYSICAL DEMANDS : (Identify any physical demands required in the performance of the primary responsibilities of the position).

TRAVEL REQUIREMENTS :