Jose P. Gisone
Life Sciences | Clinical Trials | TMF | Quality | QMS | Solution Architect | Sales Engineer | Healthcare
- Role
- Associate Director, Consulting at Just in Time GCP
- Location
- Pottstown, PA, US
- LinkedIn followers
- 500 followers
About Jose P. Gisone
CUSTOMER-FOCUSED Consultant & Sales Engineer with keen business sense and deep technical knowledge, acquired after 17+ years of successfully selling & delivering Clinical Trial, Quality & Manufacturing, ECM, and Collaboration solutions to clients in diverse industries - but primarily life sciences.* Versatile professional who thrives in a wide range of situations: delivering a sales pitch to C-level executives or coding in Java; leading teams, or being a one-man operation; staffing multi-year contracts or a week-long rapid deployment; upgrading global systems with thousands of users or implementing solutions for a single workgroup.* Proven ability to mentor junior associates while ensuring customer satisfaction that results in repeat business. Capacity to build strong client relationships via demonstrated commitment to successfully achieving project objectives.* Tactful and effective communicator; tenacious problem solver * Experienced navigating tightly controlled environments (e.g, cGxP) and deploying regulatory compliance solutions related to storage of electronic records, electronic signatures & approvals (e.g, FDA 21 CFR Part 11, 21 CFR Parts 50, 54, 56, 21 CFR Part 820, FINRA / NASD Rules 3110(c)(1)(C) and 3010(d), SEC Rule 17a-4(f), etc.) Life Sciences Software Solutions: Electronic Trial Master File (eTMF), Quality & Manufacturing (QMS), Research & Development (Regulatory, RIM). Healthcare: Clinical Archiving, Content Enabled EMR.
Experience
Associate Director, Consulting
May 2023 — Present · Warrington, PA, US
Our clients run clinical trials to discover life-saving treatments. My client-facing responsibilities include leading implementations of systems that allow trials to be run more efficiently and comply with Good Clinical Practices, provide guidance in vendor selection, and devise technology roadmaps. Internally, I spearhead efforts to leverage the most innovative technologies so our teams can provide superior services in the areas of TMF, Inspection Readiness, and other aspects of clinical trials.
Education
Camden County College
Associate of Applied Science
1992 — 1994
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