Developed actionable patient engagement and community outreach strategy. Fielded and documented clinical site requests for patient recruitment materials to ensure accurate implementation and timely follow up. Led outreach efforts to community partners to increase healthy volunteer census.

Supported site selection and initiation process. Assisted with regulatory submissions for Investigational New Drug application (IND) and New Drug Application (NDA). Reconciled essential documents of the Site Master File(SMF) and Trial Master File (TMF) in compliance with standard operating procedures (SOPs), Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines. Reviewed study case report forms (CRFs); verify entries by validating accurate source documentation. Maintained database and on-site investigator files, IRB and local laboratory documentation. Regulatory binder review and document retrieval, as appropriate for study TMF. Demonstrated proficiency utilizing Clinical Trial Management System(CTMS) and Electronic Data Capture Management system (EDC)

Lead the development, implementation and ongoing oversight for patient access programs in the rare disease business unit. Responsible for managing multiple vendor relationships to execute complex program designs. Champion strategic initiatives to ensure operational efficiency and achievement of key performance indicators. Recruit, train and support the ongoing professional development of managers. Manage program financials and profitability. Subject Matter Expert for new business development and contracting activities.Accomplishments:Grew team 10-fold to support rare disease product launch while achieving key performance indicators and implementing operational efficiencies.Improved annual reverification outcomes through implementing process efficiencies, effective reporting tools, proactive communication and vigilant performance management. These efforts resulted in project completion three months earlier than prior year. Improved program’s direct contribution margin by 27% within two months by overhauling standard operating procedures to realize efficiency gains and continuously managing staff levelsRenewed team engagement through employing bimonthly rewards and recognition activities. Employee engagement survey results for my teams reached 86% in 2017 compared to 71% in 2015.Chaired an Executive Shadowing pilot program for mid-level managers to promote organizational exposure and professional developmentCo-led proposal efforts for that resulted in a contract extension with annual revenue of $6 million and incremental growth