The opportunity
This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials…
What you'll do
Responsible for the implementation of clinical trial activities per study: protocol. Works closely with investigative site personnel, CROs, and other study vendors
Manage and coach clinical research staff.
Manage study contracting, budget and payment process for all clinical trial: vendors including investigational sites.
Partner with department head to develop department procedures and develop infrastructure.
Design study related documents, including but not limited to study protocol,: informed consent forms, CRFs, and regulatory binders.
Train CROs, vendors, investigators and study coordinators on study protocol and relevant
What they're looking for
- Monitor and track clinical trial progress and provide status update to stakeholders.
- Partner with other research and development groups to achieve deliverables.
- This role works with PHI on a regular basis both in paper and electronic form: and have an access to various technologies to access PHI (paper and electronic) in order to perform the job
- Employee must complete training relating to HIPAA/PHI privacy, General: Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
