• Contributes to the preparation of training materials (Investigator Meetings, Site Evaluation and Initiation Training for CRAs and sites)• Manages processes for planning and procuring ancillary clinical supplies.• Facilitates and collates study/country recruitment plans, communication plans, and management plans.• Creates and manages study specific tools such as recruitment and retention materials and study newsletters.• Maintains study level storyboards and overviews.• Facilitates authoring of Investigational Product Information and study specific protocol deviation listings.• Compiles IRB/EC submission documentation.• Prepares Clinical Study Team meetings and agendas, and facilitates study meetings.• Manages global versioning, revisions, and distribution of informed consent forms.• Maintains the study level Trial Master File.• Manages study vendors, such as central labs, IVRS, and suppliers of study supplies and devices.• Reconciles data from sites at a regional level between all data recording systems.• Supports and guides Regional Trial Managers/Lead CRAs with study and site priorities within specified regions.• Coordinates requests for IP shipments and receipts.• Reviews databases (CTMS, Medidata Rave, IVRS) to ensure that data is complete and correlates and performs reconciliation of data within data review timelines.

• Performed feasibility studies/site identification activities for potential sites, as requested• Coordinated study material (e.g. CRFs, manuals) shipment and receipt by study site• Ensured completeness and compiled regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification, essential regulatory documents, etc.)• Provided applicable updates for site related documentation for filing in the Trial Master File (TMF)• Assured maintenance of the Investigator Site File in the TMF • Reviewed site visit findings and assisted with resolution of identified issues• Maintained regular communication with sites• Completed remote CRF review, using electronic data capture systems• Assisted sites in query resolution• Assisted with ensuring site compliance with IP receipt, accountability and return or destruction, as applicable and appropriate• Provided mentoring and training for In-house CRA1 and CRA1

• Participated in the implementation of key organizational process improvement initiatives.• Organized, initiated, and attended project related meetings.• Compiled and prepared project related materials for internal meetings, including agendas and minutes, to ensure information was complete and accurate and facilitated project meetings.• Oversaw and maintained databases to ensure up-to-date information was continually available for review and reporting.• Tracked, reviewed and prepared study-specific information utilizing databases, spreadsheets, and other tools.• Headed coordination of negotiations of Clinical Trial Agreements and budgets with Salix legal, external legal consultants, vendors and study sites.• Reviewed and approved Clinical Trial Agreement language modifications as applicable.• Reviewed and approved budget modifications and reconciled study invoices for payment approval: inclusive of investigator grant payments.• Processed all investigator grant payments, confirmed receipt, and maintained payment histories.• Obtained, tracked and reviewed regulatory documents from sites prior to IRB/IEC submission and Regulatory for final approval of study drug shipment.• Headed coordination of Central and Local study level and site level IRB submissions.• Maintained study files according to Salix’s SOP.• Processed drug shipments and assisted with drug returns and destruction on site and remotely.• Maintained clinical supply inventory and distribution.• Communicated with sites to track upcoming patient visits, resolution of queries, and status of ethics submissions.• Assisted with the development of documents for site study binders and provided templates as needed.• Served as an internal team back up providing verbal and written communication with study personnel.• Reviewed and participated in the quality assurance of documents.