Responsible for conducting Phase I - IV studies in accordance with Federal Regulations and ICH guidelines. Planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and facilitating study meetings, overseeing the evaluation, selection and training of new study investigators.Managing the eligibility committee for medical device IVD trials.Responsible for the initial budget and contract negotiations with study sites or CROs. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate.

Clinical Research Risk Assessment and Compliance ConsultantSecondary Point-of-Contact (POC). Escalate operational issues from CRAs and site staff in support of local investigator relationship management. POC assigned for protocols in preparation and support of Global Study Manager along with global and regional Investigator needs.Consultant services provided 2018 - 2019 for Astellas Pharmaceuticals (Northbrook, IL)Site Management Interface | Global Study Management: - Accomplish protocol feasibility, site selections at study start-up through synopsis parameters outlined at study start-up via Monitoring Visit Reports for quality data outcomes.- Establish and drive local enrollment targets in alignment with global study specific plans by providing input to protocol, CRF design and operational aspects of the entire study.Study Interim Conduct | Quality Data Readiness: - Facilitate Safety Plan and Supply Chain Management End User concerns through protocol deviation Corrective Action Preventative Action (CAPA) plans.- Steer Project Inspection Readiness, Compliance and Audit Responsiveness by reviewing and actively managing timely data entry, data resolution, and reconciliation with monitoring plan

Key Point of Contact for Clinical Operations and Medical Quality Assurance. Lead risk prevention advocate for 5 Phase I-IV projects via protocol specific oversight visits (PSQRVs) on-site or remotely. Enact Project Management and Compliance:- Confirmed unpopular topics discussed, such as spontaneously high number of Protocol Deviations, upcoming IRB Site Audit, Site Temperature Excursion and root causes proactively found as the face of Pfizer for all Company assigned research studies inside and outside of the Organization. - Implemented Company-Wide Dose Titration Error Training Module. Due the COLs finding, and manual dose change via IP instructions missed by automated site and Vendor back-up systems, root cause subject dose change error was identified across multiple study sites. - Improved Phase III study Protocol Deviation Trends and IP Dose Instruction / Training applied per Phase II non-compliance Lessons Learned.External Partnership Building and Stakeholder consultation:- Liaised with as many Medical Professionals as possible across the team to ensure Good Clinical Practices (GCP) and Quality (Safe, Efficacious) clinical data results were carried out in real-time as well as in Corrective Actions.

Manage daily operations of Phase I-IV clinical studies, from study start-up through close-out activities, including, but not limited to site personnel who are both direct reports and exclusively assigned study team members. Motivate and influence clinical cross-functional team members to meet study objectives to successfully exceed site enrollment goals as defined by the protocol. Act as the Study Lead for all sites. Study Timeline Management:- Worked with Clinical Program Management (CPM) team members to ensure adherence to projected timelines, conducted weekly meetings with site monitors, Vendor to discuss assigned study site updates.- Met and exceeded enrollment expectations on more than one challenging Renal / Dialysis study team project.Communication Plan:- Managed clinical study site personnel by managing communication expectations appropriately, such that medical input (FAQ) was provided in case of emergency or when needed (i.e., face to face meetings, teleconferences, FAQ Log, 24/7 #, established e-mail inbox). - Mitigated risks proactively by conducting remote and on-site For Cause Visits per Monitor request or alternatively Flagged through ongoing weekly study management and promptly reconciled open action items to allow for key study needs.- Developed Monitoring Plan to outline specific study timelines for site initiation, interim monitoring and site close-out visit and monitored team progress cross-functionally with the Regional Managers per company SOPs. Regulatory Affairs:- Reviewed initial site-specific informed consent documents (ICDs) for ensure the study’s procedures, benefits, and risks were appropriately addresses (i.e., inclusion/exclusion, Adverse Events, Risks/Benefits, IRB Approval, Continuing Review)- Reconciled Investigator Site File and Trial Master File Documents at Study Initiation and through Study Close-Out.

Managed customer-focused Phase I-IV Clinical Trials awarded to a major CRO via request for proposal from study start to contract completion, responsible for over multi-million dollar budgets. For example, successfully completed one of the first second stroke prevention trials, highlighted direct reports/associates who excelled in their fields via performance appraisals ensuring repeat clients, careful to nurture a trusting direct report/manager relationship. Working cross-functionally as needed. Primary TA focus Cardio, CNS, Diabetes, Gastro (UC), Neurology, Pediatrics, etc.

Managed Investigator-Initiated Research Trials (TA; HIV/AIDS), conducted Rescue monitoring visits for EASNote: Jun 2004 - June 2005 Contract with Schering-Plough Reserach Intitute (sponsor no longer active), Regional CRA... Conducted SIV, Interim Monitoring Visits, Close Out Visits.

Monitored clinical research sites involved in Phase III-IV trials, then later promoted to Study Manager for Anti-Infectives, Endocrinology, Osteoporosis, and Rheumatoid Arthritis trials.