( Must Have Sponsor / Client Site Experiences) 1 Yr Contract Clinical Trial Project Specialist [...]

Support Clinical Project Managers (CPMs) and study team with administrative, documentation, TMF, budget management and logistic activities related to Clinical studies during the operational phase of clinical trials to ensure the timely delivery of quality data while complying with internal Standard Operating Procedures, applicable laws and ICH Good Clinical Practice.

• Supports high-quality electronic Trial Master Files (eTMFs). Performs set-up, maintenance (filing and approving documents) and archiving of eTMFs.
• Provides CRO oversight by developing eTMF guidelines and establishing review processes.
• Manages documentation of clinical studies in compliance with Good Clinical Practices (GCP) and relevant Standard Operating Procedures (SOPs) and perform filing QC.
• Supports CPMs with budget and invoice management: vendor creation, checking of good receipt and payments, uploading invoice information in Finance budget...