Maintenance of Trial Master File*Manage the controlled access process, including access training and monitoring*Manage study file structure process and documentation*Manage record archival and retrieval processes*Perform training cross-functionally to set expectations for filing in the TMFSupport internal and regulatory audits and inspections by making TMF contents available as neededLead Clinical Records projects as assigned*Records retention, disaster/recovery*Quality reviews of Clinical Records processes to identify issues and implement solutions*Perform TMF oversight in the form of periodic risk-based QC reviews on documents*Participate in the development, implementation, and maintenance of electronic TMFWork and collaborate with supervisor, peers, and TMF users across departmentsIdentify trends and escalate to TMF System OwnerDetermine methods and procedures on new assignmentsParticipate in system administration, SME and ad-hoc meetings to report status or updatesAdhere to CFR, GCP/ICH, ALCOAC+CEAPerform oversight management for all company wide critical documents QC review across all studiesRemediation of documents within the TMF as neededSubject Matter Expert (SME): Biostats, Safety, and back-up SME for Study Start-Up

Clinical Trial Specialist- FSP Associate for Advanced ClinicalOrganize /track study files related to SSU or other aspects of the trial as required in collaboration with the Document SpecialistGrant access to InForm through UMT for usersSuvoda, iCORE, Veeva Vault, Clinical One, MasterControlResponsible for coordinating the day to day work flow of collection and review of required document for study start. The duties include set-up, maintenance and distribution of required documentsWorks with internal Clinical Trial Managers to coordinate activities (eg, documents, study supplies, distribution of system credentials etc.) leading to SIV Assists with conducting feasibility as applicable and/or supports the documentation of decisions related to final country/site selectionEnter and maintain data into designated study tracking systemsAssist the study team with communication/contact with investigative sites/external vendorsAssist in updating study status overviews, preparation of presentations, tracking of drug supply trackingHelp to ensure audit readiness of clinical trials across all compoundsWork closely with site to assist in center initiation and study start up activitiesDocuments site and sponsor communications as applicableSupports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements as applicableCoordination and review of documents requiring translation (eg, diaries, emergency cards etc…)Customize country/site specific ICFs /patient information sheets as applicableProvides status updates to study and cross-functional teams as requiredMay be assigned Clinical Operations Lead responsibilities at the discretion of the Clinical Trial Manager Lead and/or participate in departmental work streams

Clinical Document Specialist, FSP Associate for Advanced Clinical • Assist with site feasibility including preparation, distribution, collation of responses, and documentation of the decisions related to site selection • Forecast anticipated submission/approval timelines and works with investigational sites and study teams to ensure adherence • Independent preparation, review, collection, and approval of site level critical documents required for study start up (greenlight for site initiation/release of investigational product) within agreed timelines and in accordance with ICH, GCP, and all applicable regulations, laws, and other guidelines • Review of informed consent forms used by the investigational sites including negotiating language between central institutional review boards (IRBs) and ethics committees with support from study team and legal department as appropriate • Serve as direct contact with investigational sites to assist with review and collection of site start up documents • Perform timely and accurate data entry of the status of document collection and review in the appropriate Clinical Trial Management System • Work with study team to establish Clinical Trial Master File (TMF) strategy and oversight plan • Monitor completeness and quality of the TMF (start up to archival), including elements outsourced to CRO and provide status updates to study teams • Oversee consolidation and archive preparation of the clinical TMF, liasing with CRO partners to ensure compliance with company SOPs and timelines throughout the process • Ensure effective communication and issue escalation to study team • Ensure continuous improvement of processes and quality of documents • Attend study team meetings as required, mandatory for kick off meetings •US sites, and non-US sites •Assist team while diligently providing suggestions and experience to creating the SSU tool (IP Release Milestone) for US and non-US sites•PSV waiver training

Promoted to Study Start Up Specialist I after 2 years of proving my diligent efforts, team and independent work, training colleagues on processes and systems, proven track of site start up while meeting metrics and goals.• Collected, reviewed, processed, and tracked regulatory and investigative documents for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA regulations and the Investigator Package Plan • Negotiated contracts and budgets between Sponsor and Sites• Assisted in review of core English, Country, and investigative site specific patient informed consents for compliance to respective international or country requirements and protocol as applicable • Maintained and updated document tracking information in the Trial Tracker Site Information Module and other tracking logs • Assessed impact of site personnel changes on regulatory documents and process/review new documents according to ICH/GCP guidelines • Liaised with applicable IRB/IEC regarding investigator submission/approval issues as appropriate • Setup and maintained investigative site files • Managed over 100 sites in USA and Canadian territories • Generated investigative site status reports for supervisor review • Followed project-specific and Start Up Associate policies and responsibilities • Assumed responsibility for identifying key therapeutic area investigators and consultants for external feasibility • Assumed responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required • Systems used daily: eTMF, CTMS, goBalto, Veeva Vault; Microsoft Outlook, Excel, Powerpoint; LearningPath • Reviewed Investigators’ Curriculum Vitaes for required trainings, site affiliation, and research experience • Retrieved Investigators’ status for medical licensures *Trained colleagues on processes and systems when needed

Collected, reviewed, processed, and tracked regulatory and investigative documents for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA regulations and the Investigator Package Plan • Negotiated contracts and budgets between Sponsor and Sites• Assisted in review of core English, Country, and investigative site specific patient informed consents for compliance to respective international or country requirements and protocol as applicable • Maintained and updated document tracking information in the Trial Tracker Site Information Module and other tracking logs • Assessed impact of site personnel changes on regulatory documents and process/review new documents according to ICH/GCP guidelines • Liaised with applicable IRB/IEC regarding investigator submission/approval issues as appropriate • Setup and maintained investigative site files • Managed over 100 sites in USA and Canadian territories • Generated investigative site status reports for supervisor review • Followed project-specific and Start Up Associate policies and responsibilities • Assumed responsibility for identifying key therapeutic area investigators and consultants for external feasibility • Assumed responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required • Systems used daily: eTMF, CTMS, goBalto, Veeva Vault; Microsoft Outlook, Excel, Powerpoint; LearningPath • Reviewed Investigators’ Curriculum Vitaes for required trainings, site affiliation, and research experience • Retrieved Investigators’ status for medical licensures