• Implements and monitors clinical trials to ensure sponsor and investigator obligations are met and compliant with applicable local regulatory requirements and ICH guidelines.• Performs investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents, and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH GCP guidelines, project SOPs and sponsor requirements.• Performs source document verification, independently performs case report forms (CRF) and performs query resolution in a timely manner while overseeing device accountability and safety at investigative sites according to IVD guidelines.• Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.• Generates reports for site and project management using CTMS and Works under supervision to manage workflow to accomplish assigned objectives.

. Provided oversight/execution of feasibility, selection set up, conduct and closure of clinical trials within the allocated regions, per ICH-GCP, applicable legislation and Company Standard Operating Procedures.• Served as the primary contact for day-to-day site management.• Developed clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision.• Ensured applicable trial registration from study initiation through posting of results and support publications as needed.• Provided management/oversight of ordering, tracking, and accountability of investigational products and trial materials.• Interfaced and collaborated with site personnel, IRBs/ECs, contractors/vendors, andcompany personnel.• Oversaw the development and execution of Investigator agreements and trial payments.• Responsible for clinical data review to prepare data for statistical analyses andpublications.• Performed monitoring activities including site qualification visits, site initiation visits,interim monitoring visits or close out visits based on study need.• Contribute to the development and delivery of appropriate strategy sessions for globalprojects.. Responsible for delivery of assigned clinical projects, through effective partnership withthe study core team leading to delivery of clinical project commitments (deliver on time,within budget and in compliance with regulations and SOPs);• Tracked and managed assigned project budgets to ensure adherence to business plans.• Support clinical scientific discussions with regulatory agencies/ notified bodies to drivesupport of the clinical and regulatory strategy.• Developed a strong understanding of the pipeline, product portfolio and businessneeds.• Serve as the clinical representative on Product Development team.

Responsible for supervising, monitoring, and supporting the administration and progress of clinical trials. Monitors and conducts oversights of all visit types while ensuring adherence to GCP, ICH, SOPs and applicable compliance with all study procedures while serving as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol related issues and escalating as appropriate.

Monitoring the progress of clinical studies at investigative sites, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements while governing minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance and objectives and cooperation with other project team members.Governed

• Responsible for all aspects of conducting clinical trials to ensure strict protocol and Food and Drug Administration (FDA) guidelines are met as well as study budgets and timelines.• Communicated with study sponsors, primary investigators as required by the needs of the study and work closely with the comprehensive team.• Coordinated trial participants covering informed consent, screening, and inclusion of the subjects adhering to safety and compliance issues.• Assessed patients for inclusion, exclusion criteria, and appropriateness of study participation.• Maintained complete records for each study in an organized manner that meets regulatory criteria.• Source document creation and management.• Dose study participants with study drug(s) per protocol and randomization.• Ensured participant safety was a priority through observation and collection of adverse events.• Coordinated and submitted all necessary forms, protocols, and consents to IRB.• Performed venipuncture, preparation of specimens, handling, packaging, shipping of hazardous materials to the appropriate sites.