PHRI is seeking a Research Data Manager (regular full time) to join the OCEANIC-STROKE study team.
As a research Data Manager, you will:
- 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.
Qualifications include:
- Undergraduate degree in Business, Computer Science, or a Health-related field.
- Minimum 3-4 years previous experience in multi-centre research studies (with large clinical datasets), or commensurate experience
- Advanced experience with database management, programming, development, and use of database.
- Broad knowledge of research methodology, clinical trials and drug development processes.
- Highly efficient computer skills, extensive experience with the Microsoft office suite.
- 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.
- Preferred: Working knowledge of PHRI systems, processes, organizational structure and SOPs.
- 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.
- 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.
- Extensive knowledge of ICH-GCP Guidelines and international research requirements.
This is a Hamilton Health Sciences regular full-time posting: 37.5 hours/week Monday through Friday, based in Hamilton, Ontario.
For more information - and to apply - go to: Job Number 114511
Deadline for applications: Aug 6, 2024, 11:59:00 PM.
