• Management of drug substance/API through clinical finished goods distribution to global depot locations and clinical sites through study setup activities, representing Logistics in meetings, and oversight of distribution activities.• Monitoring of clinical order process/fulfillment as executed by 3rd party distributors. Raising order fulfillment issues to management and key customers and proposing mitigation strategies on a routine (daily/weekly) basis.• Works closely with Operations peers to avoid interruptions in supply and to ensure clinical products are available at clinical sites for uninterrupted patient dosing• Involved in distribution operations aspects of clinical trials, in relation to IXRS functionality, depot selection, courier selection, order management, and study closeout. Acting as a contact for internal customers (Clinical Operations, Clinical Planning, QA) and distribution vendors for all distribution related topics for the trial protocols.• Responsible for investigation of deviations and CAPA implementation in a timely compliant manner• Uses continuous improvement methodology to drive and quantify cost optimization while maintaining customer quality and service. Ensures and maintains distribution, transportation and warehouse budgetary goals to achieve the best cost and delivery possible.• Utilizes communications skills to develop effective working relationships with peers, management, and customers to maximize efficiencies across the organization.

•Manages all the day to day clinical trial issues: Manual drug shipment requests, IXRS threshold changes, expiry monitoring of drug, drug accountability, drug returns, product complaints, and/or other site/CRA reported drug issues that require Sponsor oversight•Allow a single process for temperature excursions to be processed within Biogen Idec•Track Import licenses: works as liaison with CCLs, CRO, regulatory, and logistics to ensure continuous supply for clinical trials•Serve as an unblinded resource to GCO in referral to drug related issues and provide oversight of the blinded/unblinded interface with third party blinded trials•Serve as a key resource to measure how well the CRO strategy is working at a trial performance level and help identify best practices, as well as areas for improvement.•Reviews Pharmacy Monitoring Reports•Provides centralized clinical trial issue tracking and metrics: -Will identify trends across the portfolio, measure performance of our processes, and identify where corrective actions are needed for rapid implementation. •Identifies trends across the portfolio•Measure performance of the PO&T processes and identify where corrective measures are needed for rapid implementation•Provide risk based monitoring metrics for site pharmacies

• Built relationship with investigators and site staff remotely• Conduct general site contacts in accordance to the study specific Monitoring Plan, which may include: • Review recruitment plan and enrollment updates • Follow-up on appropriate site related questions • address/resolve issues pending from the previous visit • address protocol questions • check on site staff assignment • assess drug/study supply status • request outstanding documents • review site payment status • follow-up on data entry, query status and SAEs• Generate contact reports in accordance with departmental timelines• Conduct remote visits (initiation, monitoring, termination)• Collaborate with CRA on site issues/actions• Perform regular reviews of site level data (e.g. CTMS, EDC, IVRS, ISIS) and ensure timely and high quality data entry compliance from sites• Train site team members on study specific tasks• Support sites with drug / supply issues• Responsible for the follow up on CF QC findings raised by RMAs• Update all relevant tracking systems on an ongoing basis• Maintain site staff details in CTMS• Collect updated/amended regulatory documents in collaboration with CRA and CTS as needed• Provide collected documents to ROA for tracking, coding, scanning and uploading to TMF/sending to study mailbox, where possible• Create and distribute study document with support of ROA, as applicable• Inform responsible COL of work status regularly• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOP and stud specific procedure (e.g. Monitoring Plan)

-Action site selection strategy-Train team members on selected tasks-Refine project-specific site selection strategy at a country level.-Identify new potential Investigators and enter/update information into tracking systems-Ensure feasibility, review, and approval of site identification lists-Conduct country-specific feasibility, site pre-qualification, remote qualification visits, and site selection activities-Create country-specific/site-specific Informed Consent Form (ICF)-Prepare & negotiate Clinical Site Agreement at a site level-Prepare & submit Institutional Review Board (IRB)/Ethics Committee (EC) applications until final approval received (initial submission/Amendments)-Customize SRP guidelines-Collect & compile regulatory documents-Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC) personnel as required

• Oversee conduct of multiple oncology clinical trials within DF/HCC.• Confirm Inclusion/Exclusion parameters and register eligible patients onto appropriate clinical trials.• Report serious adverse events within timely manner to NCI/FDA/sponsors via appropriate reporting forms (medwatch, AdEERS, IRB submission).• Monitor patient’s throughout duration on clinical trial for toxicities, compliance, and best response. • Submit Annual Reports to the FDA per federal guidelines with Investigator-held IND Clinical trials.• Assist in Oncology trials initial submission process with the IRB, collecting investigators’ FDF’s. NCI investigator applications , protocol submissions, IND safety letter submissions, and FDA submissions.• Complete regulatory submissions including deviations, violations, amendments and continuing reviews.

• Monitor long term follow-up schedule of patients enrolled in long-term clinical trial in the prevention of Type II Diabetes.• Complete Annual Submissions with Institutional Review Board.• Track Informed Consent Form & Protocol changes via amendment submissions.• Report Serious Adverse Events per FDA & study-specific regulations.• Manage data entry; respond to queries, submit all data via online data software systems.• Maintain study subject binders; ensuring all source documentation is complete and verified.• Attended national study-wide meetings for regulatory certifications.

• Perform laboratory audits assuring GLP compliancy on testing performed in animal facilities.• Review data and reports detailing results of medical device testing for submission to the FDA.• Evaluate and update department-wide protocols, involved in testing procedures