Title: Clinical Trial Manager
Location: Regional or Office Based
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Clinical Trial Manager reports to the VP, Clinical Operations. He/she responsible for the successful planning, implementation and execution of clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear vendor and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by TG Therapeutics
The Clinical Trial Manager will assist in the following day-to-day tasks including but not limited to:
––Work with Study Manager to define program targets for clinical monitoring staff.
––Develop and implement Clinical Monitoring Plan.
––Develop site/monitoring tools and training materials.
––Review and identify trends in data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
––Set and enforce project timelines with the assigned study team.
––Coordinate remote review of clinical data within EDC system.
––Oversee monitoring visit schedule to ensure compliance in Clinical Monitoring Plan.
––Approve trip reports and follow-up letters within required timeframe.
––Schedule and manage weekly CRA project team meetings.
––Ensure CRAs assigned to team receive therapeutic and project-specific training.
––Assure that the appropriate SOPs TG Therapeutics are followed.
––Ensure all project documentation is appropriately filed per TG Therapeutics SOPs.
––Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
––Minimum of 2 -3 years as a successful Clinical Trial Manager.
––Prior experience as a Clinical Research Associate.
––Thorough knowledge of clinical research process.
––Knowledge of FDA regulations and their practical implementation.
––Strong verbal and written communication skills.
––Proficient computer skills.
––Proficient with Microsoft Office Word, Excel and Power Point.
––Ability to manage and prioritize workload effectively.
• Willingness and ability to travel domestically and internationally, as required.
University or college degree, or certification in a related health profession