Manage BPH and Stricture registry and clinical studies for a drug-coated balloon medical device. Project Planning and Execution:Developed and executed clinical trial plans, timelines, and budgets in alignment with study protocols and regulatory requirements.Led cross-functional teams to ensure timely delivery of project milestones.Monitored study progress to meet project goals, addressing issues proactively to ensure trial success.Regulatory Compliance and Protocol Adherence:Ensured compliance with GCP, ICH guidelines, and regulatory bodies such as FDA and EMA.Managed submission of regulatory documents, including INDs, NDAs, and annual reports.Team Leadership and Collaboration:Coordinated multidisciplinary teams (e.g., CRAs, data managers, statisticians) across multiple sites and countries.Led regular project meetings to communicate trial progress, risks, and updates to stakeholders and senior management.Vendor and Site Management:Oversaw site selection, initiation, and monitoring activities to ensure optimal site performance and adherence to protocol.Risk Management and Problem-Solving:Developed and implemented risk mitigation strategies to address potential delays or issues during clinical trials.Budgeting and Resource Allocation:Managed project budgets, tracked expenses, and ensured financial accountability across multiple studies.Data Management and Quality Assurance:Collaborated with data management teams to ensure data integrity, timely data collection, and database lock.Stakeholder and Sponsor CommunicationStudy Protocol Development and Documentation:Developed study protocols, informed consent forms, and other trial documentation in compliance with regulatory requirements.Training and Mentoring:Trained and mentored junior project managers, CRAs, and site personnel on clinical trial processes, protocol specifics, and best practices.

Working for a company that specializes in ensuring clinical research compliance through services including project management, monitoring, auditing, training, safety monitoring, site support, and research consulting. Working with sponsoring companies, contract research organizations, and investigators to assist in the device, biologic, and pharmaceutical research processes.Responsibilities include:•Conducting site periodic site visits and writing reports of findings from site visits•Conducting remote review of electronic data, identifying and following up on discrepancies, and performing on-site source data verification•Assisting sites with regulatory documentation, and ensuring appropriate documents are sent to the sponsor•Identifying and following up on compliance issues•Training research coordinators and physicians on study protocols and federal regulations/requirements related to clinical studies•Providing support and assistance to clinical research sites •Acting as a liaison between sites and the sponsor and CRO Accomplishments:•Assists with creating CRFs•Assists with training co-visits for new monitors•Participated in an eTMF Sponsor audit

Experienced in analysis of hemodynamic, electrocardiograms, respiration, temperature, and activity data of pre-clinical research trials.Experienced with GLP regulations including CFR Part 11, and OECD Principles on GLP.Developing and maintaining DSI validation documentation.Primary investigator experience with multiple toxicology studies.Working with the Institutional Animal Care and Use Committee (IACUC).Responsible for developing and sustaining good rapport with clients.

Experience creating and managing genetically modified laboratory animals including knock-in/knock-out mice and nonhuman primates.Involvement in creating and maintaining potent adenoviruses and testing for induced genetic recombination using RT-PCR, CRISPR-CAS9, TALEN, and Zinc Finger Nucleases.Experience in maintaining cell cultures.Experience in sequencing DNA and RNA using many different laboratory tests. Bioinformatic experience in taking genes from sequence to predicted protein structure and possible protein-protein and active drug site interactions.