The Research Data Specialist II will support the Data Manager I-II, Research Project Coordinator I-III/Research Project Manager IIII to oversee the management and reporting of data.

The Research Data

Specialist II may also act as an internal team leader responsible for the central data management coordination of one or more multicenter research studies or as a supporting team member. Collaborate with study team to design and improve workflows between data management with other study processes (e.g. IP management & site management). Assist with 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). Resolve difficult queries or complicated data issues. Assist with writing, implementing, and updating the data management plan, data validation guidelines. Assist with the design, creation, requesting, and testing/validation of reports (data quality, quality control, DSMB reports, central statistical data monitoring reports). Take and process Helpline calls site assistance with EDC, ROME and Protocol requirements. Communicate with participating clinical centres regarding data issues and query resolution. Develop study support tools, reports, and trackers (i.e. manuals, instructional documents). Development and maintenance of CRF variable mapping according to organizational standards (e.g., CDASH/SDTM/PHRI). Facilitate creation and publishing of databases from development, user acceptance, and production environments in coordination with Clinical Data Operations and Statistics teams. Assist with PHRI Program/Department level improvements in data collection and database build practices and processes. Assist with the design and creation of other databases for the project (e.g., monitoring database, screening database), as required. Other duties as assigned.

- Undergraduate degree in Business,



Computer Science or a Health-related field.
- Minimum 2-3 years previous experience in multi-centre research studies, or commensurate experience.
- Experience with database management, programming, development, and use of database.
- Knowledgeable of clinical trial data management practices.
- Proficient in Microsoft Office Suite.
- Act as a confident problem-solver who can work independently, adapt to constant change, take initiative, self-motivate, be flexible, and multi-task.
- 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.
- Working knowledge of ICH-GCP Guidelines and international research requirements.
- Familiarity with electronic data capture software and data authoring software such as

Framemaker, iDataFax, TrialMaster, RedCAP.

- Preferred: Working knowledge of PHRI systems, processes, organizational structure and SOPs.

Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.

To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website. This job posting is for an existing vacancy.

Hamilton Health Sciences is an equal prospect employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom,



Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact Human Resources at (phone hidden), Ext. 46947 for assistance.

If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.

This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.

If this position is temporary, selection for this position will be as per the outlined Collective Agreements:

Article 30 (k), CUPE Collective Agreement

Article 10.7 (d), ONA Collective Agreement

Article 13.01 (b) (ii), OPSEU 273 Collective Agreement

Article 14.04, OPSEU 209 Collective Agreement

Article 2.07 and Article 13, PIPSC RT Collective Agreement

Monday-Friday; days The Population Health Research Institute (PHRI), a joint institute of Hamilton Health Sciences and McMaster University, with over 300 employees working directly with 60 researchers. PHRI conducts clinical research internationally in 105 countries and is a world leader in large, global health and population and health outcomes research. Our capacity to conduct multiple international studies concurrently, with tens of thousands of participants in each, is a capability very few organizations in the world can match.

📌 Research Data Specialist II (Ontario)
🏢 Hamilton Health Sciences
📍 Ontario