Responsible for planning and managing overall clinical operations for global clinical trials/programs within the Rx Strategic & Innovation Group (SIG). This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables.

Project Leadership and Delivery• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement• Leads clinical team to ensure quality, timelines and budget management• Accountable for the financial performance of assigned projects• Accountable for all project deliverables for assigned projects• Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues.Reporting and Communication• Accountable for maintenance of project information on a variety of databases and systems• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files• Provides oversight for development and implementation of project plans in accordance with Controlled Documents• Independently prepares, coordinates and presents project material at internal and external meetings• Directs the activities of assigned Project Support staff• Prepares project management reports for client and management• Implements resource strategies to achieve project goals• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goalsBusiness Development• Participates in bid defense meetings where presented as potential project manager• Develops strong relationships with current clients to generate new and/or add-on business in the future

As a small, start-up medical device company, Torax Medical offered the unique experience of hands-on, direct involvement with all aspects of an IDE pivotal clinical study from site selection through PMA submission of clinical module to FDA. Worked independently with minimal supervision to manage 70% of the enrolling investigational sites. Study enrollment was completed ahead of schedule with excellent follow-up compliance for endpoint assessments at 12 months. Clinical Research Associate (CRA)Managed all aspects of clinical trial at assigned clinical sites to include:Trained clinical site staff to study investigational plan and procedures; including working with sites that had not previously participated in industry sponsored clinical trialsIndependently performed site initiation, interim monitoring and site closeout visits to ensure compliance with protocol and procedures, SAE reporting and device accountabilityRecommended strategies to clinical sites to recruit subjects Managed budgets, Clinical Trial Agreements and IRB communicationsPerformed Electronic Data Capture (EDC) training with all sites during start-up phaseWorked closely with sites to ensure data was entered into Electronic Data Capture (EDC) system in a timely manner and queries were promptly addressed which enabled database freeze less than 30 days after the last follow-up was completedEnsured data integrity through source document verificationDeveloped electronic filing system and document tracking tool for IDE trialLead an internal audit of sponsor files to ensure preparedness for FDA BIMO audit