Job Description

The Research Data Manager I will coordinate all aspects of data management in a clinical project at PHRI. The Research Data Manager I will work with Research Data Manager II, Research Project Manager I-III and Research Admin Assistants roles. They will work under the direction of a Research Project Manager or (Assoc.) Program Manager, Research Operations, in conjunction with the study Principal Investigator (PI) to oversee the conduct of the study from conceptualization to completion.
Oversee the design and workflows between data management with other study processes (e.g. IP management & site management); Oversee the design, creation/setup, testing/validation and modification of database setup documentation (page map, visit map definitions, annotating CRFs for biometric programmers, testing, sending to Sponsor for user acceptance testing (as applicable if external Sponsor); Design, create, request, and test/validate reports (data quality, quality control, DSMB reports, central statistical data monitoring reports); Lead meetings with stats, ICT and biometrics programmers to provide training on the protocol and to provide support for study database/randomization system/report setup; Responsible for the creation of data transfer plans, data exports and/or import transfer processes to the study sponsor and/or central lab or other (as applicable), validation of test data import/export; Write, implement, and update the data management plan, data validation guidelines, and train applicable staff on the plan/guidelines to ensure understanding and consistent review of site reported data; Provide guidance to Research Data Specialist I-II, other internal staff, and sites on query resolution; Provide training and administer data management expectations to Research Project Coordinators I-III, Research Data Specialist I-II roles, including through team meetings; Oversee the development and maintenance of CRF variable mapping according to organizational standards (e.g., CDASH/SDTM/PHRI); Oversee the creation and publishing of databases from development, user acceptance, and production environments in coordination with Clinical Data Operations and Statistics teams; Oversee the user acceptance testing documentation for new database builds and mid-study changes (MSC) for existing databases; Lead PHRI Program/Department level improvements in data collection and database build practices and processes; Design and create other databases for the project (e.g., monitoring database, screening database), as required; Develop training material and provide training to PHRI staff (Research Data Specialists, other Research Project Coordinators) on study data management processes; Work with the Research Project Manager I-III to create budgets and budget justifications for various grant applications and and work in collaboration with Finance to verify that budget is appropriate; Other duties as assigned.Qualifications1. Undergraduate degree in Business, Computer Science, or a Health-related field.
2. Minimum 3-4 years previous experience in multi-centre research studies (with large clinical datasets), or commensurate experience
3. Advanced experience with database management, programming, development, and use of database.
4. Broad knowledge of research methodology, clinical trials and drug development processes.
5. Highly efficient computer skills, extensive experience with the Microsoft office suite.
6. Minimum 3 years previous experience with data sources such as SQL and Data Collection Systems such as TrialMaster, iDataFax, RedCap, and Interactive Web Randomization Systems.
7. Preferred: Working knowledge of PHRI systems, processes, organizational structure and SOPs.
8. Act as a confident problem-solver who can work independently or as part of a team, adapt to constant change, multi-task and manage various priorities and deadlines.
9. Highly developed communication skills (written and verbal), including the ability to work with various sites, problem solving and critical thinking skills and ability to work flexible hours.
10. Extensive knowledge of ICH-GCP Guidelines and international research requirements.As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences