End-to-end execution and management of clinical trials including study site start-up, training and monitoring; management of IRB interactions, contracts and budgets; proficiency in electronic Trial Master File (eTMF), EDC and CTMS; drug and ancillary supply chain strategy; milestone tracking and vendor management; audit and inspection readiness support.

• Review the Extended Synopsis/protocol and provides feedback /comments to Project leaders and Clinical teams• Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials• Continuously Monitor patient recruitment and adjust the resupply strategy as needed• Collaboration with internal and external stakeholders to plan the labeling requirements, packaging plan and domestic and international distribution• Monitor the distribution plan including the IVR activities, making sure that IP are delivered in good condition for patients at all time• Responsible for the Pre-Audit preparation of assigned trials, making sure that all documentations are correct and available for internal and external auditors• Liaise with local country representatives (IPM) and depots to coordinate clinical supplies packaging campaigns and/or rework operations• Constant interaction with quality (SQO), making sure that all activities related with assigned studies are within compliance• Participate in global distributions meetings and cooperate with the goal settings, harmonization efforts and monitoring activities

• Oversaw research and development, IVD, IDE and devices studies for FDA 510(k) submission and IVD CE- application.• Monitored clinical studies to evaluate new investigational products and performance of BD Vacutainer blood collection tubes for visual observations and selected analytes using various instrument platforms.• Responsible for planning, budgeting, executing, and monitoring clinical studies of new investigational products, sustaining engineering to support product development and post-market surveillance studies.• Coordinated and planned receipt, use and return of IUO and study products to and from site(s)• Monitored sites to ensure protocol, SOP, GCP and regulatory compliance.• Collected, monitored and reported data generated during clinical conduct in a timely manner through interactions with Clinical Data Manager and/or Statistician.• Prepared monitoring report after each site visit in accordance with SOP• Verified that all subjects or participants signed IRB Approved Informed Consent prior to participation in the clinical studies.• Set up, managed and coordinated Associate Sample Collection Program