Job Description

BA and Software Development experience preferred.

This position will oversee PHRI enterprise standards for eCRF design and data management using Electronica Data Capture (EDC) systems and to lead projects related to benchmarking and promoting a culture of best practice and offer expertise to the leadership team in data collection, data analysis, benchmarking, project development, implementation and evaluation. Job Accountabilities include: Establish and maintain procedures and standards for gathering and reporting clinical data and performing activities in database development initiatives and continuous improvement; Develop organizational data management standards using internationally accepted standards; Develop and prepare standard templates and guidance material to be shared, reused and built upon, throughout the organization; Provide input to strategic decisions for continuous quality improvement of data management within the organization; Review and provide guidance on Data Management Plans; Coordinate and support an ongoing assessment of clinical data operations activities and create and implement action plans to address opportunities for improvement; Contribute to strategic planning for individual PHRI program areas where improvement is required or desired; Review protocol with a perspective of designing a database and provide recommendations for clarity and consistency in data requirements; Review with Study team member(s), the type and frequency of data items to be collected to provide recommendations on set-up, database design and mapping of variables; Engage with the Statistics Department (Biometrics Programmer and/or Statistician) to ensure that the database design meets the statistical programming standard requirements; Provide support to develop the Electronic Data Capture (EDC) system database to meet data management standards, and performance standards to optimize data management activities; Identify, review and recommend data integrity checks to ensure the validity of the data; Provide guidance and direction with system testing and validation to evaluate system specification, user requirement and regulatory compliance prior to implementation14. Facilitate publishing of studies to UAT and/or PROD environments following established best practices and work instructions; Troubleshoot escalated issues related to the system and lead problem solving with study team; Establish and implement regular review process to look across study databases, to build and promote consistency and application of best practices and standards; Engage with study team lead to integrate data management milestones in study timelines; Work with the study team and support department personnel to lead in the promotion and coordination of best practices for roles and responsibilities, key activities and timelines
19. Monitor the implementation of database development for each new study to support best practices and required standards are met; Provide key information on data management best practices to study team and program leadership to promote and support optimal decision-making and establish new expectations for improvement across teams; Lead training sessions and provide advice and expertise to staff in terms of data management standards, best practices and database development; Lead the development, delivery and evaluation of database templates and manuals; Lead, as the subject matter expert, in teaching program and department staff on the use of databases, report creation, data analysis tools and other resources; Mentor and provide recommendations and advice to Clinical Data Operations staff; and Other duties as assigned.

Qualifications

1. Post-Secondary Degree in Business, Computer Science or Health Related Field
2. Minimum of 5 years experience in a health related field or clinical research is preferred
3. Minimum of 5 years experience with Project management and quality improvement methodologies, tools and techniques is preferred
4. Minimum of 5 years experience of advanced computer competencies and data analysis such as SQL and Data Collection systems such as DataFax, Omnicomm TrialMaster, REDCap
5. Proficient in MS Office Suite including MS Word, Excel, Power Point, MS Project\xe2\x84\xa2, MS Visio and SharePoint\xe2\x84\xa2
6. Ability to understand and demonstrate application of key concepts in: database management, computer systems, data analysis, quality improvement, benchmarking
7. Ability to effectively work in teams in balance with an ability to work independently and offer creative and innovation solutions
8. Excellent communication skills (oral and written)

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences