Allan Morales Email and Phone Number

- Manages and performs quality control for the Trial Master File, ensuring compliance with industry standards and regulations. - Assists with study start-up, including budget and contract development.- Coordinates distribution of documents and materials to sites and vendors.- Tracks and reports on study milestones, documentation, and regulatory submissions.- Prepares study-related materials and maintains shared file drives.- Leads project-based assignments and creates process documents for Clinical Trial Assistants.- Assists in writing and reviewing SOPs and supports clinical operations systems.- Provides general administrative support, coordinates meetings, and manages communications with sites.- Handles vendor and site invoices and maintains regulatory knowledge.- Offers mentorship to junior Clinical Trial Assistants and manages license agreements

• Support Clinical Operations Study Lead with clinical trial activities, including oversight of outsourced activities to Clinical Research Organizations (CRO) and other third-party vendors• Execute assigned operational tasks, assist in tracking study metrics, maintain and distribute study trackers• Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples• Interact with clinical trial sites to foster relationships and support collection of relevant study materials/ documentation• Support Clinical Operations Study Lead in collection, tracking, and maintenance of clinical trial documentation and regulatory documents for the electronic Trial Master File (eTMF)• Review TMF documents for completeness, accuracy, and compliance with protocol and appropriate regulations as part of the quality review process; acts as primary liaison with the CRO to collect trial documents and coordinate review of the eTMF to ensure inspection-readiness at all times; Identify issues and take appropriate corrective action• Assist in the preparation of study related documents (i.e. ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.)• Support project meeting logistics such as: calendar management, room & equipment set up, collation of materials, and attendance tracking. Under the direction of the Clinical Operations Study Lead, prepare meeting agendas and a draft of meeting minutes• Coordinate the logistical aspects of vendor and investigator meetings• Develop and maintain financial trackers for each study to track vendor invoices, Purchase Order balances, facilitate Clinical Operations Study Lead review and approval of all vendor invoices, and reconcile inconsistencies, as needed

• Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.• Assist the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates• Perform study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents• Assist with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies.• Provide study materials and supplies to the study sites and Clinical Research Associates (CRAs).• Assist with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports• Participate in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items• Perform review of clinical data listings• Under general supervision, manage third party vendors in the every-day conduct of a clinical trial (central lab, reading center, IRB)• Participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)• Assist with other duties and projects, as needed• Subject Matter Expert on the uploading and maintaining of MRI/CT data from sites.

• Key Clinical Operations support role; ensures that delegated components of clinical trials are executed to expected and specified quality standards• Builds basic knowledge of clinical trials operations and scientific principles and objectives of BeiGene’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others• Learns best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations• Ensures understanding of clinical trial protocols and site specifications and the scientific/medical objectives of the clinical trials• Verifies that data collected in trials is consistent with protocols• Reviews monitoring reports; checks for adherence to trial metrics; and assesses sites against clinical trial protocol specifications.• Ensures patient enrollment activities are within protocol guidelines• Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies• Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings. Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking• Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of these activities• Provides study level information to enable accurate and efficient supply of clinical product to the sites• Adheres to Clinical Operations processes and SOPs

• Serve as the steward of the study eTMF to make sure the process to ensure completeness, quality and timeliness is followed by the study team.• Effectively communicate and drive document management compliance and quality issues to the clinical study teams and management.• Present eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF• Support the clinical study teams to ensure study TMFs are submission and inspection ready at all times.• Prepare the study specific TMF plan and corresponding study inventory list and insure they are current throughout the study and finalized at study completion.• Conduct documentation reviews of the TMF looking for areas missing significant documentation, logical checks (missing versions, missing documentation from 1572 participants, correct number of sites, etc), gross errors in location, inconsistencies in naming conventions.• Ensure QC reviews are conducted as prescribed in the TMF plan and that issues identified are addressed• Support the study team during inspections and audits as necessary.• Present eTMF at study Kick-off meeting and investigator meetings (CRA training) and attend regular study team meetings as applicable to report on the status of the TMF• Manage deletion/demotion requests throughout the duration of the study (Once Veeva eTMF workflow is in place)• Answer any filing queries or general Veeva eTMF questions from CRO/study team• Ensure Veeva eTMF is set up for the study and that countries and sites are added as needed

• Maintain global operational tracking and reporting systems and tools including but not limited to the study/project budget and financial management data • Develop study specific tracking systems if applicable • Provide detailed support for cost tracking (study budgets, project budgets and special events)• Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication• Assist and collaborate in development of project / study related documents• Support Clinical Study Report preparation (e.g. appendices) • Coordinate project / study material preparation and global study communication internally and/or with vendors• Create and send communications materials to countries and/or study sites (e.g. Newsletters, updates, etc.) • Coordinate communication of project/study status to various levels of management • Responsible for setting up, maintaining on ongoing basis, providing expertise in quality controlling and archiving of the global Trial Master File (TMF) (paper TMF or eTMF)• Provide technical knowledge of the “essential documents” as described in the SOPs.• Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers• Participate and support audits (Regulatory Authorities and QA), inspections and verification of TMF• Ensure the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and approval of new medications and medical devices • Provide technical expertise for the eTMF • Provide consultative guidance on new systems, processes and procedures (e.g. SharePoint, inspection readiness, etc.) • Provide technical expertise of the budget and payment systems (for assistance with forecasts, actual cost updates, etc.)

•Establish and maintain a working listing for new business accounts.•Act as a local contact for Spanish speaking businesses.•Coordinate the contracts and terms with all Spanish businesses.•Administer training for new processes and technology to all associates and customers•Communicate with sales force to contact new sales leads and devices.•Liaison with Hispanic Chamber of Commerce to acquire new accounts

•Work with the trial teams to organize Trial documents as per defined structures•Understand the differences between multiple structures (similar to Trial Master File) for multiple type of trials•Create folder structure as per requirements and migrate the existing documentation on a shared drive into the new structure•Check whether the documentation is available for every trial based on defined checklists•Migrate the content from shared drive to similar structures on SharePoint portal•Liaise with off-site team to import documents into documentum•Main point of contact for clinical team for document issues

•Act as local trial leader in management and conduct of clinical trial.•Communicate with global team to implement changes required of local regulations.•Act as point person to IRBs when changes and answers are required.•Responsible for the execution of clinical trials (e.g. trial timelines, resources, eligibility, enrollment and data consistency).•Establish and maintain working relationships with external site personnel and internal team.•Writing of trial related documents (e.g. Informed consents{localized}).•Monitor and track trial progress and implement changes to ensure timely, quality deliverables.•Responsible for the content of trial related communication to internal and external customers (e.g. newsletters, site/CRA trainings).•Responsible for the trial master file and trial documentation according to SOPs/WPDs and GCP/ICH guidelines.•Oversight of data management activities of a trial and works with the CRAs/sites to ensure timely resolution of data issues .•Liaises with Project Finance Manager for budget development.•Lead trial team meetings.•Liaises with Payments group.

•Participate in the selection of investigators and study sites.•Serve as a primary contact for the sites, responding to issues and recommending corrective actions.•Monitor and track clinical trial progress and providing status update reports.•Manage interactions with contract research organizations (CRO's) and other vendors as required.•Interact with Regional Field Managers and Monitors as appropriate, coordinate monitor teleconferences.•Verify and review investigator qualifications before releasing investigational drug.•Keep up to date inventory for both drug and CRF levels.•Process all site payments for study, based on enrollment performance.•Collaborate as part of the Study Team with Data Management, in the development of case report forms and participate in the EDC process, when appropriate.•Participate in the planning of investigator meetings and making presentations as required.•Participate in the response to audit findings of investigator activities.•Participate in the review of clinical data at the CRF, data listing, and report table levels.•Author patient narratives for submission in the CSR•Verify validity of eCTD submission for the FDA•Verify complete file structure for eCTD submission – no missing documents•Answer questions and requests during FDA inspection•Participate in the preparation of project and study related documents including: oClinical trial outlines, synopses, protocols, and amendments. oInvestigators Brochures, IND Annual Updates and other documents as required. oClinical study reports, abstract presentations, and manuscripts of clinical study findings and results.

•Support members of the study team to implement and manage study activities from initiation to closeout.•Track and process site and vendor payments.•Support and correspond with investigative sites, including ordering study drug and other trial related supplies.•Collect and review study related regulatory and financial documents. Distribute copies to appropriate departments.•Perform start-up activities for a 106 site study.•Organize and maintain project working files and track critical documents for 2 studies.•Transmit and reconcile all essential documentation for CDIC to maintain integrity of archival files.•Collect trial enrollment information and update study management reports under guidance of the Clinical Scientist/Clinical Trial Manager.•Assist with the preparation of clinical team meeting agendas, minutes and monthly site newsletters.•Communicate and support field monitors, IRBs and outside vendors as to study issues and updates.•Participate in the planning, preparation and on-site support of investigator’s meetings, making brief presentations at the meetings occasionally.•Contribute to process improvement efforts including task forces and committees.

•Effective management of timelines and meeting of deliverables.•Attend Investigator Meetings for support, collection and training on all regulatory documents required by the trial.•Assists in the coordination of central IRB submissions, ensures accuracy of central IRB invoices, and obtains LTM approval for payment.•Provide support to Local Trial Manager (LTM) by distributing and tracking investigator feasibility questionnaires.•Responsible for the collection, review and follow-up of regulatory documents for accuracy and completeness. oTransmits FDA 1572 and CV to Regulatory for submission to the FDA. Follow-up throughout the study to obtain revised 1572’s. oHighlights modifications of the Informed Consent after review and submits for approval and finalization to the LTM. oCoordinates site-specific ICF translations as needed. oInitiates and tracks confidentiality agreements with sites and maintains investigator and site contact information. oKeeping accurate records in order to process investigator payments in a timely manner. •Responsible for the maintenance of all data and forms in CTMS(Siebel 7, eClinical)•Communicates clearly and effectively with sites, colleagues, and functional manager.•Processes, tracks, and distributes documents as required for protocol amendments with supervision of LTM/Functional Manager.•Prepares Trial Master File (TMF) for archiving at study completion.

•Conducts investigative site recruitment/feasibility•Acts as a liaison with clinical supply/service vendors•Prepares investigator and study site materials and tracks clinical trial management information•Performs feasibility evaluations and identification/recruitment of investigators •Performs investigator recruitment and essential document collection and review activities•Ensures that the study files are current, accurate, and complete•Review and approve ICFs in accordance to ICH and GCP guidelines•Review and track SAEs in accordance to ICH and GCP guidelines•Answer questions concerning Protocol Procedures, CRF completion and keep track of all ongoing issues at site and region level•Collects, logs, tracks, and maintains site-related essential and non-essential documents•Responds to site requests and site/patient issues as a Command Center representative•Prepares timely metric reports of the status of clinical investigations•Performs training classes pertaining to new procedures and implementations for Documentum•Completes all necessary training to ensure understanding and first hand knowledge of Documentum usage and deployment.•Creates phone scripts, questionnaires, and other assessment tools for use in evaluation of investigative sites•Participates in sponsor and project-related meetings and interacts with client, as required per project•Monitors one or more clinical investigations by on-site co-monitoring visits, telephone contacts and correspondence. Reports all contacts on appropriate forms.•Schedules and helps to perform study initiation and closure visit activities at investigational centers.•Continuously update and distribute Documentum related training and applications.•Provide immediate solutions to Documentum related issues

•Maintains Document Security and Integrity in a controlled environment within Documentum•Ensures accurate set-up, maintenance, delivery and archiving of files •Performed budgetary metrics to ensure best project resource workload utilization•Ensures Project team compliance to Document Management processes by continual training and development of helpful tools•Review incoming regulatory documents for accuracy and completeness•Work as leader of document management Work Groups and eTMF (electronic Trial Master File) mentor. •Provide first line of help between end users and the system.•Prepares investigator and study site materials and tracks clinical trial management information with several different means, including databases and spreadsheets•Collects, logs, tracks, and maintains site-related essential and non-essential documents; reviews site-related essential and non-essential documents for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements•Related Courses Taken at PRA International: oEssential Document Identification oPRA E-TMF® Process- Clinical Operations- ISSC workflow oDocumentum Navigation oDocumentum Applications & Trouble Shooting oEssential Document Review oMedical Terminology oDrug Development Process oClinical Operations SOPs and GCP Compliance oHIPAA Compliance Training Classes o21 CFR Part 11