Mitch Mcgee Email & Phone Number

Novato, Ca, Us

Novato, California, Us

Novato, California, Us

Novato, California, Us

Experience:• Leader of the CTA/CTS Forum to promote cross-program transparency and coordination• Created multiple process maps for start-up, maintenance, and close-out processes• Helped to lead the WAR Room for a mock inspectionResponsible for:• Reconciling and maintaining the Veeva Trial Master File (eTMF) for three studies• Distribution of SUSARs and other program-wide communications• Set-up and maintenance of CTMS• Coordinating communication of tracking information within the study team and to the clinical sites• Managing, tracking, and facilitating study contracts, payments and supplies • Creation and tracking of purchase orders• Mentored multiple Clinical Trial Associates• Serve as a subject matter expert for the CTS role on 3 initiatives• Manage central lab vendor

Novato, California, Us

Experience:• Participated in WAR Room for both EMA and FDA inspections• Protocol Amendment QC review• Final Database Lock line listing reviewResponsible for:• Reconciling and maintaining the Veeva Trial Master File (eTMF) for three studies• Distribution of SUSARs and other program-wide communications• Set-up and maintenance of CTMS• Collecting, distributing and tracking regulatory documents• Preparing and tracking study-specific information using databases, Excel spreadsheets and other tools (Ex: sample reconciliation, visit projections, enrollment metrics)• Managing, tracking, and facilitating study contracts, payments and supplies • Creation and tracking of purchase orders• Member of multiple initiatives to promote development of department culture• Set up, coordinate, and host meetings. Distribute relevant documents, take and distribute meeting minutes.

Paso Robles, California, Us

Guiding tours of the vineyard with an emphasis on the winemaking process, agricultural process, and local history. My skills with public speaking have grown and developed and allowed me to form and maintain relationships.

San Rafael, Ca, Us

• The internship position had three main objectives: timeline, budget, and scope. I shadowed a project manager and observed the process of managing an enzyme replacement drug project in phase three of clinical trials. • Compiled a prioritized list of study metrics and routinely coordinated with colleagues in three countries. • Prepared presentations for all levels of the company from floor engineers to vice presidents.

San Rafael, Ca, Us

• Created an automated Excel workbook that tracked shipments between 41 countries in real time.• Developed a process map of the entire supply chain procedure from start to finish locating lag time and redundancies.• Created drafts of several SOPs that have since been applied by the company. • Worked extensively with Microsoft Project and Visio.