Description
The Senior Clinical Trial Manager is responsible for ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.Other responsibilities include:
* Manages the study project plan, including timeline, budget, and resources
* Participates in study strategy development, protocol, CRF development, Clinical Study Report preparation and NDA submission
* Proactively identifies potential study issues/risks and recommends solutions
* Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
* Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
* Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
* Participates in the development, review and implementation of departmental SOPs and processes
* Serves as a liaison and resource for investigational sites
* Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
* Participates in the selection, training and evaluation of study personnel to ensure the efficient operation of the function
Requirements:
* Bachelors Degree, Science or health related field
* 5+ years of related clinical trial management experience
* Experience in managing CROS, specialty labs and outside vendors
* Global study management
* Experience with infectious disease highly desired
* Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
* Must have the ability to build and maintain positive relationships with management, peers, and direct reports
* Excellent written and verbal skills. Must display strong analytical and problem solving skills. Attention to detail required.
* Ability to travel 20 - 30%
To find out more about Real please visit www.realstaffing.com