Clinical Trial Oversight Manager

Responsibilities :

Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues

Provides support of clinical study execution

Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross functional environment

Responsible for review and approval of FSP Quality Oversight Monthly reports

As requested, conduct in-person or remote Site Quality Visits to promote and maintain site quality and collaboration Requirements / Qualifications :

Doctorate degree OR

Master’s degree and 2 years of experience OR

Bachelor’s degree and 4 years of experience OR

Associate’s degree and 8 years of experience OR

High school diploma / GED and 10 years of experience

Familiarity with advanced concepts of clinical research

Extensive knowledge of ICH / GCP regulations and guidelines

Strong knowledge of clinical trial operations

Understanding of Functional Service Provider operational model