Kwame Ofori Email & Phone Number

Houston, Texas, United States

I expertly oversee and direct global clinical trials of Cordis’ medical device portfolio packages to obtain CE Mark or FDA approval for commercialization. I lead the selection and management of appropriate vendors (CROs, Core Labs and Electronic Data Capture System vendors) within budget parameters, driving the project’s direction. I have complete oversight of global investigator solicitation, research site/ teams’ feasibility assessments, qualification and selection processes, Trial Master Files, budgets and contracts development and management, project timeline development, startup, conduct, and closeout in compliance with all Federal & MDR regulatory, quality, and safety laws and guidelines. My leadership skills help support and influence global vendors and research teams in achieving deliverables that meet objectives of achieving CE Mark or FDA approvals. I skillfully direct project budgets and contracts development, stakeholder reviews and execution, and track life cycle costs ensuring appropriate funding documentation. I proactively assess startup and implementation risks and develop alternate and critical pathways for risk reduction with minimal impacts to study timelines and budgets. I develop and manage project tracking systems to effectively track project startup, conduct, and closeout milestones for regular reporting to all stakeholders. I am skilled at scheduling and leading high-level research project meetings across the globe and across different time zones to address all startup, conduct and closeout items and resolve all pending issues in order to keep the project conduct within the timeline. I also lead weekly and bi-weekly meetings with the study vendors to discuss study progress, vendor specific issues and impacts on study budgets and timelines, and resolution plans. I provide direct input in the development and approval of documentation to guide the engagement of DSMBs and CECs.

Santa Clara, California, United States

Houston, Texas, United States

I skillfully handle the management of NASA’s human performance research designed to identify and mitigate risks associated with space travel and habitation, providing direction to Principal Investigators to implement NASA’s strategic vision. I have full oversight of global research teams, project inception, investigator solicitation, award/ budget management, project startup, conduct, and closeout management in compliance with all Federal regulatory, quality, and safety laws and guidelines. I apply leadership skills to support and influence research teams in achieving deliverables that meet objectives of paths to risk reduction. I deftly manage portfolio budgets and track each study’s life cycle costs ensuring appropriate funding documentation. I proactively assess startup and implementation risks and develop alternate and critical plans for risk reduction with minimal impacts to study timelines and budgets. I also develop and manage project tracking systems to effectively track project startup, conduct, and closeout milestones for regular reporting to all stakeholders. I smartly lead high-level research project kickoff meetings to address all startup, conduct and closeout items and issues. Also, lead quarterly meetings to discuss study progress, issues, and resolution plans. I review annual and final Principal Investigator reports ensuring accuracy and all deliverables are met.

Houston, Texas Area

Clinical Research Manager – Electrophysiology/ Cardiovascular Device ResearchUT HEALTH SCIENCE CENTER - HOUSTON, TX (2014 – 2019)Research Management:I maintain comprehensive oversight of study resource assessment and deliverables from startup through closeout, including timelines, research contracts/ grants and budget negotiations, development and submission, CMS coverage analysis, and performance outcomes, effectively aligning project objectives with regulatory policies and institutional guidelines. I deftly demonstrated subject matter expert in managing research site qualification, including site capability assessments, personnel, and other resource review and allocation. I improved study revenue by 15% through robust budget negotiations, incorporation of a revenue tracking tool that tracks standard of care and professional services costs.External Partnership Development:I skillfully directed the scheduling and participation of high-level stakeholders' (PI team, sponsors, IRB, Office of Sponsored Projects, Hospital Research Office) meetings to discuss research direction and resolution of key issues to assure smooth study conduct Human Resource OversightI expertly directed and managed research personnel hiring, training, and supervision; managed personnel's daily work time, vacation, sick time, and timesheet sign-off ensuring strict adherence to work time requirements; Implemented training programs to ensure personnel remained current on research training requirements. I directed the research team’s relocation efforts including the facility design, utilities, furniture, and moving companies.Research, Data Analysis, and ReportingI prepared weekly research reports by reviewing CRFs and identifying SAEs, protocol deviations, and communicating such reports to all stakeholders while ensuring adherence to federal and ICH GCP guidelines. I Managed the development of research quality documents (MOPs, SOPs, Master Data Plans, and Codebooks).

Houston, Texas Area

As the Program Manager of Research, I was an expert team facilitator who managed cross-functional project teams in early phase drug development and directed analysis enabling strategic decisions on program direction. I had three critical sectors that I provided leadership and was responsible for: Research Project Oversight, Quality Improvement Strategy and Implementation and Research, Data Analysis, and Reporting.When it comes to the Research Project Oversight, I directed and managed research site initiation, including site capability assessments, personnel, and other resource review and allocation, timelines, and management while adhering to federal and local regulatory policies. I significantly increased study quality by developing and maintaining regulatory, compliance, QC, and QA documents and implementing monitoring plans; Closely monitored and managed clinical trial conduct, developed meeting schedules, agendas for cross-functional teams, ensuring that project risks effectively communicated, monitored and managed. As for the Quality Improvement Strategy and Implementation, I served on Memorial Herman Hospital’s stroke steering committee and contributed to defining project strategies. I worked with Memorial Herman Hospital’s emergency department committee and joined cross-functional teams to develop strategies to mitigate stroke patient care delays on arrival. I also prepared weekly research reports by reviewing CRFs and identifying SAEs, protocol deviations, and communicating such reports to all stakeholders while ensuring adherence to federal and ICH GCP guidelines; managed the development of research quality documents (MOPs, SOPs, Master Data Plans, and Codebooks).Key achievement: Tracked patient care time metrics to guide future efforts, with over 80% year-over-year time improvement and Documented all study data requests and managed data query, abstraction, and quality control processes.

Houston, Texas Area

As the Mission Integration Specialist and Cost Account Manager, I interfaced with NASA biomedical research and clinical teams initiating astronaut research planning, including multi-site capability assessment, recruitment strategies, equipment, and supplies assessment, monitoring plans, the delegation of responsibilities and study closeout planning.I managed astronauts biomedical research pre-, in-, and post-flight for 10 space shuttle missions between 2006 and 2012. I recognized for flawless management of research activities of multiple astronauts across several geographical regions.One of my biggest hurdles during this tenure was managing astronaut research activity schedules to eliminate conflicts with several other important requirements. I overcame that challenge by constant communications and negotiations with other activity schedulers to effectively switch schedules and still assure astronauts’ safety and on-time research data collection. I effectively managed research activities of both US and international astronauts utilizing knowledge of both US and international regulatory policies through 10 space shuttle missions.Key achievements: Recognized for flawless management of research activities of multiple astronauts (including international astronauts) across several geographical regions and through multiple Space Shuttle Missions | Recognized by the shuttle crew with certificates of appreciation following each shuttle mission |

Master Of Science - Ms, Cancer Biology, Prevention And Control

Activities and Societies: Sigma XI, Scientific Research Society

Master Of Science (Ms), Cancer Biology, Prevention And Control

Bachelor Of Science (Bs), Agriculture, Agriculture Operations, And Related Sciences