Project Manager Associate
TFS Healthscience
03.2022 - 09.2025
- Provide electronic access to all systems and tools required for the management of the study.
- Setup, maintenance and accurate periodic update of study information in the Clinical Trial Management System (CTMS).
- Setup and maintenance of study contact lists, action and decision log and FAQ log.
- The administrative tasks of the study.
- Preparation and tracking of trial-related documents, tools and templates.
- Study status reporting, collection of appendices for final clinical study reports as well as document translation process.
- Support planning and logistic for meetings to include internal and external meetings and aids in finalizing and distribution and filing of meeting minutes including Investigator Meetings.
- Actively take part in study meetings and be responsible for the meeting minutes during the calls as well as lead meetings with the team, vendor and sponsor.
- Act as central contact for the study team.
- Send and track project communications to the study team and sites.
- Attend activities associated with audits and regulatory inspections.
- Management of Investigator Payments and invoices.
- Actively contribute to the organization and development of processes to enhance the work at TFS.
- Develop and maintain an effective relationship with the study team and Sponsor.
- Supervise, support and training to other study team members as deemed necessary.
- Setup and tracking of the Investigator site files.
- Maintain the study master file (usually via SharePoint or as otherwise specified in the SOPs).
- Coordinate and distribute study supplies as deemed necessary.
- Support PMs/CRMs/CRAs and TMF Associate with collection of documentation and running reports on helpful missing documents, status of documents, reconcile the eTMF on a quarterly basis.
- TFS (continued)