Robert Byrne Email & Phone Number

Vancouver, British Columbia, Canada

- Lead Data Manager for two Phase 1 oncology studies with different clients, one study in Merative Zelta EDC and one in Medidata Rave- Provide daily Data Management guidance and data management expertise to internal study teams.- Update meeting agendas and represent Data Management to external clients in weekly calls. Participate in meetings regarding eTMF, Risk Review, Protocol Deviations etc- Created/programmed over 300 Patient Data Surveillance listings in new Medidata 'Data Surveillance' platform to facilitate thorough DM review of historical data for a complex rescue study - Innovated complex Excel macros to automatically convert ALS into company database specifications template, benefiting all data managers in the department and saving manual work- Subject matter expert on Medidata Data Surveillance system. Led internal demonstrations showcasing PDS system to various internal study teams to pitch system to clients, gained 'buy-in'- Engaged with Medidata and provided constructive feedback gained from experience in first production study utilizing PDS-Executed two database amendments in each EDC system, adhering to strict timelines and ensuring seamless collaboration between data management, programmers and sponsors.- Led a global team of three Clinical Data Associates, providing comprehensive training via Teams calls and directing data review activities, showcasing strong leadership and mentoring skills.- Consistently provided scheduled weekly metrics, Medical Monitoring reports, SAS listings, Coding reports, Clean Patient Tracker, PSC dashboards to both internal and external stakeholders- Authored specifications for programmed SAS listings and requested programmers with internal ticketing system- Accountable for accuracy of all DM documents in eTMF- Authored and gained signatures for DMP, eCCGs, DTAs, Data Transition Plan, Data Review Plan- Responsible for monthly DM study budgets and requesting out of scope costs - Oversight of external vendors

Allschwil, Basel-Country, Switzerland

• Data Manager on over ten studies as the sole data manager or within local data manager teams • Performing 100% CRF data review in Medidata Rave and various data listings. • Performed data tracking, review, cleaning, validation, reconciliation, query management, freezing and patient locking throughout studies, using numerous databases and software tools.• Discrepancy management for paper and EDC studies, data freezing clean patients• Collaborating daily with DM colleagues, study team members, vendors and global CRAs via TCs, email, and in person meetings• Formulating queries on behalf of Medical Coders, Clinical Science and Statistics. • Daily CRF review including eligibility criteria, Study Visits, Medical History, Concomitant Medications, Adverse Events, Study Drug Log, Drug Accountability, Study Completion• Creating test data and performing User Acceptance Testing of edit checks and eCRF pages.• Reviewing central and local laboratory data issues and querying flagged issues (out of range, sample re-tests, duplicates) • Critical thinker and creative problem-solver• Ability to work on multiple projects at once• Met critical study deadlines under pressure including DB go-live, data cut-offs, Interim analyses, Database locks• Medidata Rave listings and 360 reporting• Adherence to ICH-GCP, 21CFR11, SDTM and CDASH standards• Writing DMP, Data Review Manual, CRF / eCRF Completion Guidelines and SOPs• Ability to work independently and in teams in multi-function corporate environments• Creating eCRF Completion Guidelines from screenshots in Rave, demoing eCRF in walkthrough meetings• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint, Teams)• Assigning or QC’ing Protocol Deviations from Protocol Deviation Code List.• Proficient in various clinical databases for paper studies (Oracle Clinical, MS Access) and EDC (Medidata Rave)• Knowledgeable in medical terminology

Berlin, Germany

• Worked on largest phase III hematology study ever undertaken by the company.• Part of a large local study team consisting of 25 data managers.• Used Medidata RAVE on a daily basis for data review and query management.• Had to meet a target of opening/closing 200-300 queries per day to help clear a back-log of 10,000 queries in the system. The target was met and each member of the team received a monetary bonus.• Performed hard-locking of data clean patients in RAVE.

Allschwil, Basel-Country, Switzerland

• Performed query management and data review for Phase III paper-based study in the indication of PAH.• Used in-house database system to send queries, typed investigator replies into system and updated database as required.• Filed and archived paper queries with the CRFs. • Attended weekly meetings and provided feedback to Study Data Manager

Manchester, England, United Kingdom

• Worked on two paper-based studies in phases II and III for the indications of Scar Prevention and Reduction (varicose vein removal and skin grafts)• Used Oracle Clinical to work through approx. 10000 un-actioned discrepancies • Emailed DCFs and corresponded with monitors throughout Europe and Russia• Worked through resolving approx. 5000 DCFs returned from sites (updating DB, CRF, DCF, tracking spreadsheet)• Performed final database QC• Both studies successfully database locked on schedule

Diss, England, United Kingdom

• Worked on a European oncology phase III study (bone metastasis in lung cancer patients) for a top 10 pharma Sponsor • Handled and tracked receipt of CRF pages and pre-reviewed before data entry• Reviewed data using validation programs and generated External Data Clarification Forms to email to monitors.• Edited the database from resolved DCFs and signed off queries in the system• Assisted in the development and testing of validation programs, provided feedback to IT• Adhered to quality documentation such as Data Processing Guide, Validation Plan, and Protocol to ensure the data is of high quality and to ICH-GCP standards

Sydney, New South Wales, Australia

• Worked on phase III global oncology study (colorectal cancer) involving 3450 patients, part of a large local data management study team working alongside overseas Basel team.• Worked on phase II lung cancer study and was sole data manager for 150 patients from 19 sites in 9 Asia-Pacific countries. Main point of contact for monitors.• Used Oracle Clinical to action discrepancies on a daily basis in conjunction with Study Assumptions Document, Data Specification Guidelines and Data Entry Guidelines.