Providing clinical strategy and management services to CROs and biopharma clients.

As Executive Director, Clinical Operations, was responsible for the oversight and performance of all Clinical Operations staff (50+), Business Unit resourcing, budget forecasting and accuracy, establishing and managing preferred provider relationships with multiple vendors, leading Clinical Operations RFP responses and bid presentations and new systems assessment and implementation. Lead all interdepartmental and vendor oversight that included Data Management, Pharmacovigilance and Partner CROs outside of the United States.Successfully helped develop and implement a Study Start-up Unit, strategically changed the CTMS/eTMF systems to reduce annual costs to sponsors by over $300,000 and combined positions to improve Clinical Operations’ efficiency and effectiveness. Pushed for and assisted with the involvement of AI use in Clinical Operations.

Provided operational support for Clinical Operations and Data Management and an advisor for the project teams. Accountable for strategy, clinical trial execution, timelines, resource planning, budget forecasting and management. Served as senior project interface with clients in role of senior project manager or project advisor. Primary clinical operations contact for proposal development, proposal defense, and other business development responsibilities. Lead cross-functional teams to provide high quality and timely execution of deliverables and overall trial service to the customer ensuring all projects were conducted according to GCP/ICH Guidelines. Developed and maintained strong, collaborative relationships with key stakeholders inside and outside the organization. Ensured maintenance of corporate systems by collection of data to be included in the metrics database, sponsor database, investigator database, and protocols database and assisted with development of clinical protocols and SOPs.

Responsible for supervision of multiple projects and project managers, ensuring project staff follow all SOPs, are fully trained, writing and updating project plans, ensuring project managers meet study timelines, monthly unitized budget management and projections, drafting CAPAs, responding to vendor and client audits and Director-level interaction and management of study sponsors.

Responsibilities include:1) Plan and lead all clinical activities, 2) KOL engagement and management, 3) Assist with regulatory affairs including FDA meeting and interaction, 4) Develop procedures as needed, 5) develop and manage study budgets, 6) negotiation and management of site and vendor contracts, 7) vendor management, 8) all other duties as needed

Co-founder of a device start-up, investigating LED technology in the inactivation of MRSA and other bacteria.

A consultant to Pharmaceutical and Device companies, specializing in clinical operations development and management. Provided study design and implementation as well as clinical support of/input on 510(k) submissions. Additional services included project management, monitoring and the ability to pull together a team that includes data management, stats and regulatory strategy and compliance.Pharmaceutical therapeutic area experience includes:Cardiovascular: Vascular Surgery, Exercise Induced Tachycardia, Hypertension, Pulmonary HypertensionCNS: Alzheimer’s Disease, Migraine, Chronic Daily Headache, Parkinson’s Disease (with & without Psychosis), ADHD, Schizophrenia, Traumatic Brain Injury, Epilepsy, Diabetic Neuropathy, Respiratory: COPD, Asthma, ARDSUrology: Erectile Dysfunction, BPH, AUROncology: Prostate CancerDermatology: Pressure Ulcers, AcnePain: Osteoarthritis, Rheumatoid arthritis, Analgesics, Morphine, Neuropathic Pain, Opiod infusionRenal: Liver Transplant, Renal Allograft, Kidney DialysisAnti-infectives: Pneumonia, Candidiasis, Amebiasis, Pediatric Infectious DiseaseGastroenterology: Endoscopy, Opiod Induced ConstipationGenitourinary: Hypo-gonadism, Progesterone DeficiencyDevice/Biotech experience includes:Surgically implanted ethmoid sinus stentMultiple implanted pain pump studies in adults with cancer related painMulti-biomarker lab test and corresponding reader for possible appendicitis in childrenLED device for acne and 510(K) submission

Served as the Director of Clinical Operations and responsible for all aspects of the clinical department including establishing SOPs, clinical training, site selection, resourcing, clinical budget development and management and overall study oversight.

App development for travelers which would allow them to order food in advance of their arrival to an airport.