The Clinical Research Data Manager (CRDM) is responsible for research data management (RDM) activities involving the design, administration, data collection, validation and testing for CCI clinical trials and registries. The individual will be responsible for planning and collecting data from clinical trials and ensures that data collected is accurate and grouped properly, solve any operational problems, and prepare statistical reports.
The CRDM will report to the CCI Director of Research Operations. Will work closely with other staff to fulfill the operational requirements of the research group.
- Serve as the Lead Research Data Manager on multiple clinical research studies
- Reviews research protocols to provide data collection related feedback
- Develops a Data Management Plan (DMP) and a Data Validation Edit Check Plan for each trial
- Collaborates with CCI team members on data transfers, data cleaning, creating and analyzing large datasets and other data management issues relevant to research
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Develops and refines project DM documentations (DMP, Data Validation Plans etc.) based on good RDM practices
- Develop Case Report Form (CRF), electronic and/or paper in consultation with Clinical Study Coordinator
- Create standards in CRF setup and edit checks to ensure consistency and efficiency in database development
- Participates in the review of Clinical research documents (e g. Protocols, Case Report Forms, Reports and Statistical analysis) and provides guidance on RDM practices
- Develop standard procedures/reports to validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures and up to date research data management systems
- Extract and monitor the trial data to identify issues
- Participates in the preparation and presentation of research data, when applicable.
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
- Mentor or train other junior members
Work closely with PI and CCI Study Coordinator. Work with general direction and supervision from the PI/Director, Research Operations as part of a collaborative team. This individual will be expected to work independently in accordance with established objectives; and exercise initiative and judgment in performing all work-related function.
Provide mentorship to new or inexperienced research staff.
Consequence of Error/Judgement
Errors in the management of data could result in inaccurate data sets, inadequately analyzed data, as well as the loss of productivity for the investigators and the potential loss of grant or other research funding.
Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. The performance of clinical trials and research projects must strictly conform to appropriate regulations:
1) personal: maintaining professional behavior and respect for subjects and staff
2) local: the UBC Clinical Research Ethics Board
3) Provincial: B.C. Privacy Act
4) Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and
5) International: U.S. Food & Drug Administration.
- Bachelor’s degree, or recognized equivalent, in Computer Science, Mathematics or Statistics.
- Minimum 3 years of clinical research data management experience in a health-related setting.
- Experience with clinical data collection, monitoring/auditing as well as clinical trial documentation using Electronic Data Capture systems is required
- Experience using Database Management systems such as, iDataFax/ DFDiscover and RedCap preferred.
- Knowledge and experience in statistical software SAS and other relevant software platforms such as Oracle InForm, PL/SQL, Visio is required.
- Knowledge of ICH/GCP guidelines
- Excellent project management skills
- Strong analytical and problem-solving skills
- Demonstrated ability to express complex technical concepts effectively
- Mentor/training experience
- Strong verbal and written communication skills
- Exceptional organizational skills and customer relations
- Excellent problem recognition and problem-solving abilities
- Excellent listening, conflict resolution skills
- Client service oriented, with the ability to effectively work with diversity
Equity and diversity are essential to academic excellence. An open and diverse community fosters the inclusion of voices that have been underrepresented or discouraged. We encourage applications from members of groups that have been marginalized on any grounds enumerated under the B.C. Human Rights Code, including sex, sexual orientation, gender identity or expression, racialization, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.
All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.
UBC Off-Campus Hospital Sites
Staff – Non Union
M&P – AAPS
AAPS Salaried – Research and Facilitation, Level B
Clinical Research Data Manager
Wood Laboratory Division of Cardiology | Department of Medicine | Faculty of Medicine
$5,468.83 – $7,878.17 CAD Monthly
Posting End Date
July 13, 2021 Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date
Jul 15, 2022