Inclusion without Exception
Tata Consultancy Services (TCS) is an equal opportunity employer, and embraces diversity in race, nationality, ethnicity, gender, age, physical ability, neurodiversity, and sexual orientation, to create a workforce that reflects the societies we operate in. Our continued commitment to Culture and Diversity is reflected in our people stories across our workforce and implemented through equitable workplace policies and processes.
TCS has been serving the Canadian marketplace for more than 35 years and today is the technology partner of choice for many of the country's leading organizations. As one of the largest IT services providers in Canada and globally, TCS is aiming to become the world's largest AI-led technology services company and is enabling its clients to transform themselves across the full AI stack, from infrastructure to intelligence.
Rooted in the heritage and values of the Tata Group, TCS is focused on creating long-term value for its clients, investors, employees, and the communities it serves. With a highly skilled workforce supporting customers from coast to coast, TCS has consistently been recognized as a Top Employer by the Top Employers Institute, including a recent top ranking at the country level.
TCS also sponsors 14 of the world's most prestigious marathons and endurance events, including the TCS Toronto Waterfront Marathon, reflecting its commitment to health, sustainability, and community empowerment.
eCRF Document Specialist (Document Publisher CMC)
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline
- Master’s degree is preferred
Role Summary
The eCRF Document Specialist will support electronic case report form documentation and electronic submission readiness activities. The role involves formatting, standardizing, optimizing, reviewing, and performing quality checks on clinical trial documents according to established standards and timelines.
Key Responsibilities
- Perform electronic submission readiness activities for different types of eCRF documentation, including:
- Subject CRF
- Annotated CRF (aCRF)
- Sample CRF
- Define documents
- Clinical Study Data Reviewer’s Guide (cSDRG/SDRG)
- Standardize document and file names according to established naming conventions.
- Create and maintain the required folder structures for clinical trial documentation.
- Format documents according to applicable standards and submission requirements.
- Optimize documents and perform quality control checks within established timelines.
- Review completed documents using the designated document-review tool to ensure accuracy, consistency, and high-quality deliverables.
- Identify and resolve issues during the document review process.
- Consolidate queries or issues identified while processing files for specific clinical trials.
- Communicate queries to the appropriate points of contact and provide potential solutions for consideration and formal approval.
- Ensure all assigned documents are completed accurately and delivered within the agreed timelines.
- Perform additional responsibilities or activities assigned by the supervisor.
Required Skills
- Basic understanding of clinical trial documentation and eCRF processes
- Knowledge of CRF, aCRF, Define, cSDRG, and SDRG documents
- Strong document formatting and publishing skills
- Good attention to detail and quality
- Ability to follow naming conventions, templates, and document standards
- Strong organizational and time-management skills
- Ability to identify, document, and communicate processing issues
- Good written and verbal communication skills
- Ability to work independently and collaboratively within a team
Preferred Skills
- Exposure to clinical document publishing or electronic submission readiness
- Familiarity with clinical research or pharmaceutical documentation
- Experience with document optimization and quality-control processes
- Familiarity with automated document-review tools
Salary Range - CA$ 90,000 - CA$ 110,000 Per Year
Tata Consultancy Services Canada Inc. is committed to meeting the accessibility needs of all individuals in accordance with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code (OHRC). Should you require accommodation during the recruitment and selection process, please inform Human Resources.
Thank you for your interest in TCS. Candidates that meet the qualifications for this position will be contacted within a 2-week period. We invite you to continue to apply for other opportunities that match your profile.
