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. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director

• 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 laws and regulations

• 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 is quality data within budget and timelines• 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 tracking; providing status updates; project communication; information/data gathering and reporting; coordinating and facilitating meetings; tracking, escalating and resolving issues; tracking and mitigating risks; contingency planning and managing resources

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, biostatistics, vendors) to lead and drive project implementation and management; primary point of contact for sponsors/clients/upper management for study related issues/items • 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.