Research Data Specialist II

Hamilton Health Sciences • Hamilton, ON

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Working knowledge of PHRI systems, processes, organizational structure and SOPs.

Responsibilities

• Oversee the management and reporting of data.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level