Jeff Greenway Email & Phone Number

Calgary, Ab, Ca

Calgary, Canada

- Currently working in 2 Phase I, first in human, solid tumour, oncology trials, with multiple sites.- Experience with Audits, including pre-audit interview, onsite management (during audit), and post audit CAPA resolution.- Working on more than 5 phase III clinical trials in Hematology/Oncology Therapeutic Area in anadult population- Experience on over 3 virology studies, both as a blinded and unblinded monitor.- Conducted all trial specific subject activities, including… Show more - Currently working in 2 Phase I, first in human, solid tumour, oncology trials, with multiple sites.- Experience with Audits, including pre-audit interview, onsite management (during audit), and post audit CAPA resolution.- Working on more than 5 phase III clinical trials in Hematology/Oncology Therapeutic Area in anadult population- Experience on over 3 virology studies, both as a blinded and unblinded monitor.- Conducted all trial specific subject activities, including patient enrollment, randomization, dataentry into different clinical systems and IP management- Maintained patient and regulatory files, monitored patients for safety and adverse events,maintained protocol compliance and FDA regulatory compliance- Ensured quality of data through Source Data Verification, Source Data Review in conjunction withCentralized monitoring in a Risk Based approach, and Risk Based Quality Management.- Completed pre-study site selection visits, SIV, and interm monitoring visits.- Communicated effectively with sites regarding data base locks, protocol questions, patientenrollment questions, vendor access, site training, and site ICF updates.- Collaborated with remote site monitors and data management to review and improve site KPIs, and meet data base lock objectives.- Acted as primary person responsible and meeting host for post audit findings with PI, Site staff, Site managers, and Global Sponsor involved. Show less

Tom Baker Cancer Centre

- Clinical research coordinator, working on multiple actively recruiting studies in oncology (hematology, neurology, and gynecology). - Experience with Phase I, II, III, and IV trials.- Coordinating protocol activities with the Principal Investigator, Co-Investigators, Research Nurses, Pharmacy, in patient unit, and other departments, and study personnel, from study start-up, to amendments, to data updates, and study closeout.- Interacting and communicating with Research Ethics… Show more - Clinical research coordinator, working on multiple actively recruiting studies in oncology (hematology, neurology, and gynecology). - Experience with Phase I, II, III, and IV trials.- Coordinating protocol activities with the Principal Investigator, Co-Investigators, Research Nurses, Pharmacy, in patient unit, and other departments, and study personnel, from study start-up, to amendments, to data updates, and study closeout.- Interacting and communicating with Research Ethics Board concerning protocol status changes, study outcomes, SAEs, protocol deviations, changes in study personnel, and other regulatory requirements.- Working with Sponsors to gather, submit and maintain documents per regulatory requirements. - Gathering, entering, and clarifying clinical data.- Experience in a variety of EDC, IXRS, and other vendor systems.- Provides statistical information to Principal Investigator, tumor group leader(s) and Clinical Trials Research Office on ongoing trials, accrual of new patients and follow-up.- Tracking events for invoicing information.- Auditing site regulatory binders.- Creating and update best practices (Diagnostic imaging patient privacy, Transfer of Studies, Regulatory Binder Standardization, Internal Auditing). Show less

Calgary, Canada Area

- Geoscience database developement and management.

Home Based, Calgary Alberta

Contract work in Clinical Data Management

Victoria, Canada

· Oracle trainer and system expert for various data management systems (Oracle, Datalabs Clinical) within PRA.· Track milestones and deliverables, involving monitoring, managing and creating change orders to capture out of scope requests.· Provide guidance to mid-level employees on leadership responsibilities, by reviewing documents for completeness and accuracy, as well as suggesting different methods and styles for leading teams.· Facilitate and lead Client meetings, including… Show more · Oracle trainer and system expert for various data management systems (Oracle, Datalabs Clinical) within PRA.· Track milestones and deliverables, involving monitoring, managing and creating change orders to capture out of scope requests.· Provide guidance to mid-level employees on leadership responsibilities, by reviewing documents for completeness and accuracy, as well as suggesting different methods and styles for leading teams.· Facilitate and lead Client meetings, including biostatistical review interim analysis data cuts.· Facilitate and lead internal meetings, including reviewing meeting minutes to ensure the discussion was accurately captured and action points and ownership of them are correct. · Therapeutic experience in Oncology, Cardiovascular, Rheumatological, and Neurology. · Reviewing protocols for development for CRF and data quality checks. · Assisted in the development, implementation, and delivery of data management systems, training programs, standard operating procedures, and work instructions, for newly hired and existing employees.· Leading teams of over 20 people, located in different offices, countries, and continents.· Leading data management teams in the collection and review of demographic, qualitative, and quantitative clinical data. I have managed several projects, with budgets ranging from $100K to $15M. · Create and maintain documentation (ex.: quality control plan, data collection guidelines, project timelines and milestones, risk assessment and planning) to ensure documents and processes follow company and client standard operating procedures and protocols.· Ensuring data management services are delivered in a consistent, high-quality, and profitable manner (4 projects completed, audited, and sent to the client for successful submission to the FDA, and other health organization bodies). Show less

Calgary, Canada Area

Sidney, Canada

Bachelor Of Science, Combined Major Physics And Earth Science

Education record

Courses in statistics, and epidemiology