Offer summary

Qualifications:

Bachelor's degree with 5+ years of experience in clinical research or site management., Strong knowledge of Good Clinical Practice (GCP)., Experience in site monitoring and clinical trial oversight., Ability to collaborate in a cross-functional environment..

Key responsabilities:

Act as the primary contact for FSP vendors regarding resource and capacity management.

Support clinical study execution and ensure quality oversight.

Review and approve monthly quality oversight reports from FSP.

Conduct site quality visits to maintain collaboration and site standards.

Job description

Client: Biotech
Position: Clinical Trial Oversight Manager
Location: Remote - Any time zone
Type: Contract

Ideal Candidate: B.S. and 5+ YOE. Previous experience in site monitoring - CRA site management. Strong GCP

* 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

Basic Qualifications:
"Doctorate degree
OR
Master's degree and 2 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Bachelor's degree and 4 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Associate's degree and 8 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
High school diploma / GED and 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
"

Required profile