Coordinates and monitors oversight of clinical trials across Liprotamase (Cystic Fibrosis) and Blisibimod (Lupus) programs Oversees completion of study start-up, conduct, and closeout activities to industry and corporate standards to ensure timeliness of clinical studies 
Ensures progress and completion of projects according to timelines 
Prepares and presents regional project specific updates 
Leads development of clinical documents e.g. protocols, study reports, study manuals, and annual reports 
Identifies problem issues and facilitates discussion around solutions to be implemented by the clinical study teams Oversees data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation 
Leads in the construction of Clinical Operations processes including development and writing of SOPs, creation and organization of study Trial Master Files, and clarification of organization and workflow structures 
Oversees Site management activities 
Oversees development and maintenance of integrated systems e.g EDC, IXRS, CTMS, additional integrated portals 
Anticipates areas of risk, and creates plans to implement risk mitigation tactics Develops program-wide tools and processes to increase measured efficiencies 
Leads and supports clinical trial management team members on growth development
Oversees CROs, central laboratories, and overall clinical study vendors 
Prepares clinical trial budgets and contractsCollaborates in grant writing activities Manages MS Project timelines across clinical programs
Embody's leadership and accountability and influences company-wideTravels and builds relationships across industry counterparts
Manages CSR activities across functional teams and clinical operationsPrepares clinical activities towards regulatory BLA filings

Responsible for developing and maintaining program-wide MS Project timelinesInfluences teams by leading with risk mitigation focus and tacticsDevelops adjudication processes and oversees overall adjudication conductConducts site evaluations/initiations and routine monitoring visits and resolves issues e.g establishes corrective and preventive actions and documents via CAPA reportingEvaluates site compliance with the protocol, regulatory requirements and quality of dataAssists in CRO and vendor selectionsCreation and review of protocols, informed consents, case report forms, monitoring plans, and clinical study reportsReviews routine data and resolution of data discrepanciesParticipates in presentations and manuscript developmentLeads collaboration efforts and ensures accurate communication across functional teamsDevelops processes for DMC/DSMB activities to ensure patient safety and oversees scheduling, preparation and follow-up activitiesTrains CRAs and Clinical Trial Management team members Leads monthly Clinical Trial Management training on-boarding for new hiresParticipates in departmental and interdepartmental strategic initiatives

Conducts site evaluations/initiations, routine monitoring visits and closeout visitsAssures site compliance with the protocol, regulatory requirements and quality of dataResolves routine monitoring issuesAssists in the setting and updating of study timelinesAssists in CRO and vendor selectionCreation and review of protocols, informed consents, case report forms, monitoring plans, and clinical study reportsAssists in the review of routine data and resolution of data discrepanciesPrepares safety, interim, and final study reportsParticipates in presentations and manuscript developmentInterface with individuals in other functional areas to address routine study issuesAssists in the training of CRAs and Clinical Project AssistantsParticipates in departmental or interdepartmental strategic initiatives

Served as Manager for more than 15 Phase I, II, III and bioequivalence clinical trials for a CRO in collaboration with Data Management, Quality Assurance, Database, Software Development and IT.Managed site training, site surveys, IRB documentation, variances and regulatory documentsLead all CRAs in monitoring activities and trainingCo-monitored with CRAsParticipated in phase I, II & III of clinical trial CRO responsibilities, including creation and management of timelines, protocol creation, creation of project management plans, monitoring plans, eCRFs and source documents, review of monitoring reports, reporting adverse events, management of data validation and site and study close out proceduresManaged vendor relationships, including identification and selection of vendors, and established procedures with central laboratories, drug distributors, translation companies, IRBs, ECG and spirometry reviewers and CRAs Managed relationships with site and sponsor personnelOrganized and lead teleconferences with the sponsor team, CRAs and vendorsOrganized and lead internal planning meetings with the study teamsLead CTM meetings involving all departmentsSupervised the project management, help desk and central filing teamsImplemented processes via organization proprietary software, including tracking metrics, regulatory documents and maintaining the trial master fileAssisted QA with site, CRA, Sponsor and FDA audits and participated in internal auditsWorked in conjunction with QA to develop and improve project management, monitoring and study SOPsManaged and organized internal teams of data management, CRAs, project assistants and help desk technicians throughout the duration of several studies to adhere to company and Sponsor SOPsManaged and organized CRA, site staff, PI and sponsor training meetings at Investigator Meetings and on-site initiation visitsDeveloped software and study procedure manuals

Performed clinical/health care research activitiesCompleted IRB documentation and submissionsPrepared and participated in monitoring visitsPerform patient assessmentsDocumented and reviewed medical history, concomitant medications and AEsAssured compliance with study protocolAdministered study-related medications and documented effectsParticipated in creation of abstracts and postersManaged booth and attended presentations at HSG (Huntington's Study Group) and HDSA (Huntington's Disease Society of America) conferencesParticipated in Huntington's support group