Clinical QA Associate Director - (US-NJ-Branchburg - 08876)

Minimum Education: Tech School
Job Type: Full Time
Jobcode: CMS 134
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GENERAL SUMMARY

Participates in the strategic planning and implementation of Clinical QA plan. Manages the Clinical QA quality process. Conducts GCP audits of the company and sponsored clinical trials, vendors and internal processes. Prepares company and clinical sites for regulatory authority inspections; participates on inspection team. Reviews and recommends compliance related policies and procedures. Provides GCP training and mentoring. Evaluates impending regulations, guidelines and industry standards and their impact on clinical trials and company. assists in management of Clinical QA consultants. Note this position requires up to approximately 35% travel.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Contributes to strategic Clinical QA planning and risk assessment; manages CAPA plans.
Manages the Clinical QA quality system.
Plans and performs internal and external GCP audits, as either lead or co-auditor, to ensure that clinical research activities are in compliance with applicable regulations.
Issues audit reports and recommends corrective action.
Provides timely written reports to inform management of the company’s regulatory compliance status.
Prepares company and clinical sites for regulatory authority inspections. Acts as on-site inspection coordinator as needed.
Responsible for management of clinical trial complaints.
Performs GCP training. Trains and mentors junior level auditors.
Assists with management of Clinical QA consultants.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

BA/BS in Health Sciences or a related field.
At least 5 years of Clinical QA experience required, including planning and performing internal and external GCP audits.
Extensive knowledge of GCP regulations, Part 11 regulations, guidelines and clinical QA audit process.
Ability to effectively manage multiple projects.
Excellent written and oral communication skills and interpersonal skills.
Demonstrated problem solving and decision making skills.
Strong training skills.
Ability to effect change within an organization.