Clinical Research Project Manager

This position require physical attendance in office:

Tasks:

Provide and oversight and direction to the project team, including specifications for time, quality and cost of deliverables and assure efficiency and accuracy throughout the project

Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.

Create a management framework to optimize the skills of functional leads and drives focus on the quality and efficiency of individual tasks.

Assist investigative sites with completion and submission of all required clinical trial

documents prior to site initiation.

Serve as internal support for all members of assigned project teams.