Devang Shah Email & Phone Number

Morrisville, NC, US

• Serve as Senior Project Manager/Project Lead for global (typically intercontinental) projects for one or more clients, according to Covance Standard Operating Procedures, ICH Guidelines and GCP
• Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders..

• Working on a program for the development and execution of Ph 2 clinical trials for a NME (new molecular entity) in hyperlipidemia/NASH/NAFLD and in interactions with FDA
• Also working on a program for the development and execution of a global Ph 3 clinical trial to develop and establish a project plan and budget projections for a biosimilar entity in oncology (lung cancer)
• Lead for creation and development of a robust CTMS (repository) system for the company and integration of same with eTMF
• Provide leadership and guidance in revision of SOPs/processes and development of new SOPs/processes to enable global growth of the company and ensure consistency across regions and compliance with RA/ICH-GCP/country.

• Managing and driving implementation of domestic and global trials (Ph 1 to Ph 3) from inception to completion including study close out activities through database lock and finalization of CSR ensuring project outcome.
• Excellent understanding of all tasks involved in clinical development program(s) from developing a protocol through to finalizing a clinical study report including budget and financial aspects
• Project Manager activities: clinical project initiation, budgeting, planning, execution and completion, which may include managing clinical project timelines, budgets and deliverables; process development; study.

Raleigh, North Carolina, US

• Working as a project manager independently for clinical trials
• Planning, selection and management of countries/sites/KOLs-Investigators/vendors for the study
• Working with cross-functional leads/areas (clinical monitoring, data management, regulatory, study start-up, contracts & grants, finance, legal, drug/IP supplies, safety & pharmacovigilance, medical writing.
• Working with sponsor for protocol development/submission/approval to RA/FDA/CA in U S A/EU/APAC
• Track financial projections and realization for the study and responsible for budget management

Raleigh, North Carolina, US

• Monitoring Clinical Research Phase I/II/III trial activities at study sites to assure compliance to GCPs, SOPs, and study protocols to assure inspection readiness
• Responsible for training and managing all clinical monitoring activities of all CRAs assigned to the studies including their training, resourcing and quality of reports/activities
• Participates in development and/or review of study specific site trainings, training materials and be directly involved in site personnel training on regulatory documents, protocols, policies/procedures and study forms
• Assist in managing large scale/global clinical trials - support Global CTM and PMs in ensuring all trial deliverable timelines are met

Raleigh, North Carolina, US

Clinical Research - Monitoring of oncology trials

Raleigh, North Carolina, US

Practicing General surgeon with over 2 decades of surgical experience in India.Having own practice with privately owned fully-equipped hospital with OR and in-patient facilities.