Research, analyze, and provide recommendations on feasibility/viability of multiple proposed clinical research studies/sequence of studies conducted domestically and globally. Projects have included assessing impacts of standards of care, demogaphics, healthcare systems, international regulations and guidance, ethics, and other necessary parameters for effective client decision-making in over 25 countries for Pharma clients, including for their evaluation of engaging CROs.
Evaluate start-up and expanding biomedical and biotechnological enterprises for potential investments by venture capital and fund management companies focusing on management, strategy, marketing approach and product/service offerings.
Conduct and analyze investigator and patient attitude surveys to support practical implementation of clinical research studies in ranges of disease states, including “rescue” of studies in danger of being abandoned.
Built and co-founded innovative professional services company identified as a “thought leader” in biomedical research compliance and ethics oversight routinely audited by industry and a federal Agency. Company won multiple business awards including Fast 50/500 (Deloitte & Touche) and the Blue Chip Enterprise Award (U.S. Chamber of Commerce).
In regulated environments of healthcare and financial services responding to political and business pressures for tighter oversight, provide transition leadership to Boards of Directors, including advocating more proactive and socially-responsible mission and practices.
Provided analysis and strategies to clinical research leadership and staffs of two major Academic Medical Centers under compliance scrutiny on their regulatory and risk management practices. For one, also provided remediation training of research investigators, other healthcare professionals, staff.
In responding to outside federal Agency review of policies and procedures of foremost facility of largest government healthcare system facing significant sanctions, created action plan in collaboration with primarily affected teams and monitored plan’s implementation, resulting in “no further actions required” judgment.
Developed structure and approach to address complex provisions of HIPAA, while working with cross-section of function heads of company, to become model nationally for meeting both letter and spirit of the Act.
Working with national and regional leadership, conducted first cultural audit of a uniformed services organization challenged by allegations of discrimination, fulfilling proactive commitment of organization, establishing strategy for implementing necessary change, and improving recruitment and retention of officer candidates.
Improve organizational efffectiveness through service on leadership and steering committees of two international Associations: for one, to build the enterprise; for the other, to expand Board and strategic planning capacity.
Redesigned and delivered a previously unworkable change effort, limiting damage of attempts to undermine a federal Agency director’s institution-wide revitalization initiative and increasing employee understanding of organization’s new IT and other mission delivery systems and corresponding new unit roles. Reduced amount of employees’ downtime in complying with this effort by 40%.
Designed and delivered change management initiative addressing serious Agency-wide morale problems for Office of the Secretary, working closely with impacted senior and middle management personnel and without significant legal repercussions.
Adapted change management techniques to co-develop and implement congressionally-mandated program to ease transitions from military to civilian life with result that ability to find jobs, implement successful retirement plans, and improve readiness for non-regulated nature of civilian life was mastered.
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