GCP Consultant - OQSIE

Responsibilities

Senior Manager, GCP Compliance who contributes to implementation of risk-based GCP and compliance solutions. This person will be responsible for the planning, identification, coordination, execution, reporting of the implementation of CGP Compliance solutions in support of clinical programs.

· Establish/implement clinical quality policies and procedures for Quality Management Systems supporting clinical studies: including CROs, investigator sites, independent studies, central labs, non-clinical study laboratories and other key partners supporting clinical and pharmacovigilance programs.

1. Provide GCP/GCLP consultation to Clinical Study Teams
   
   · Consultation to QA Specialist(s) with the management and maintenance of study eTMFs
   
   · Development and implementation of SOPs

1. Experience with the qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, eTMF Vendors, Investigator Sponsored Trials
   
   · Perform training and education of global GCP standards, and externally as required
   · Experience in the review of clinical and data operational plans and protocols.
   
   
   Qualifications

• Strong knowledge of global GCP regulations, guidance, and standards. Development of supporting SOP's and standards.
• Excellent collaboration and partnering skills.
• Ability to work independently and as part of a team.
• Excellent verbal and written communication skills.
• Demonstrated ability to effectively organize and execute tasks in a timely manner.
• Computer proficiency with Word, Excel, and PowerPoint. Experience with an eQMS (Veeva, TrackWise, Master Control, etc.) is a plus
• Experience working in a clinical operations function is a plus.
• Experience with the Audit and Review of Safety and Clinical documents is a strong plus
• Ability to work in a fast-paced, highly collaborative, and dynamic environment.