Bryan Stone Email & Phone Number

United States

Manage TMF teams at the project level. Supervisor to direct reports. Manage site activation activities. Vault eTMF administration. Collaborate to create timelines and budgets for eTMF deployment. Lead TMF training to internal and external staff.Develop, maintain, oversee usage of standardized TMF components including contract deliverables.

I work with clients to help them better manage their TMF from implementation to archival by providing direction to improve process. In my current role as Project Lead, my goal is to tackle the large issues faced when attempting to adhere to GCP standard and regulations.

Pennsylvania

I work with customers to ensure their personalized custom Vaults provide exactly what each customer wants and needs. I strive to ensure business needs and practices of each customer are met in full with all that Vault has to offer.

I continue to work bringing high quality solutions to the various eTMFs used at Inovio. I've proven robust oversight review techniques help to manage various eTMFs across multiple trials. I've taken ownership over entire trial eTMFs acting as a point of contact for all questioning. I provide training to all internal employees and to various external employees. I've taken on the role of mentor for an employee new to our TMF team which has proven extremely rewarding. As my role expands within the company I'm confident I can continue to learn and employ industry-leading techniques as well as innovate along the way.

I am part of a now two-man team. Together with my department lead, we are creating processes to manage and provide oversight to all aspects of TMF for the company as well as every trial we run. I help to personally ensure that each eTMF is inspection ready through the development of QC and sponsor oversight processes. I employ my knowledge and experience with GCP standards and the TMF Reference Model. I strive to learn and understand industry standards and innovate and apply each to my position.

Study Start Up activities such as feasibility follow up with potential sites, enrollment projections, and more. SOP modification for the eTMF as well as TMF Plan creation. Global Clinical Operations Representative for FedEx Account. Project Management activities including: SIV monitoring, drug supply coordination, shipping supply coordination, TMF upload/QC/audit, meeting minutes, and more.

North Wales, Pa

Provide access to study, site, and sponsor staff for various training and electronic databases and update CTMS accordingly. Identify and document site staff and associated roles. QC and enter documents into eTMF. Create/Update/Modify spreadsheets and CTMS concerning subject enrollment. Upload monitoring visit documentation for CRAs. Complete meeting minutes and ensure upload to the eTMF. Training new employees. Report directly to Project Manager and complete additional tasks for Clinical Trial Managers.

North Wales, Pa

Mentored Document Management Team in India. Assessed quality & completeness of documents. Effectively & concisely communicated how to correct errors. Assisted others with meeting their deadlines while consistently meeting my own. Trained new employees.

Bachelor Of Science (B.S.), Biobehavioral Health

Bachelor Of Science (Bs), Biobehavioral Health

Activities and Societies: Penn State IFC/Panhellenic Dance Marathon (THON), Penn State Student Red Cross Club, Penn State Song Writer's.