Clinical Trial Administrator (contract)

Duration of Contract: 1 Year

Hours: 8:30 – 5:00

Assists the Clinical Operations team in customizing existing operational plans for the study/program for multiple clinical vendors in order to achieve IND/BLA/sBLA applications and maintain inspection readiness. 

Participate and contribute to Center for Excellence initiatives to drive continuous improvement and delivery of business technologies that are operational in a study/program/franchise. 

Assists Global Clinical Project Leads (CPL) by tracking compliance to all study level plans and escalating any variances. This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways.

Involved with moving studies quickly into data review/closeout period. If experienced with reviews or data reconciliation, this is helpful. TMF (Trial Master File) experience is needed. Experience w/ CSRs is helpful (but not as critical). QC of study docs – helpful.

Less focus on monitor report review; but some vendor management experience.

Will be the SME for the TMF system.

Must be comfortable producing and updating docs for study startups and closeouts.