TMF Document Specialist

About the job

HCLTech is a global technology company, home to more than 218,000 people across 59 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2024 totaled $13.7 billion.

The TMF Document Specialist is responsible for ensuring the quality of documents in the TMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of document issues with Document Owners / TMF Study Owners or other end users.

RESPONSIBILITIES :

Process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents

Demonstrate understanding of document types, properties and indexing requirements

Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy

Process documents in the TMF system(s) within specified timelines, based on document criticality / priority

Communicate document inquiries with responsible users as needed

Liaise with Document Owners, TMF Study Owners and / or other end users to resolve document related discrepancies and issues

Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed

Contribute to process improvement initiatives and projects that may arise

Can be identified as Subject Matter Expert for TMF process, systems and related tools.

EXPERIENCE :

Hands-on experience with electronic documentation management systems and / or web based data management systems

Records management experience in a highly regulated environment (preferably clinical research) or experience working with clinical / medical records

Experience / knowledge of ICH / GCP documentation requirements

History of achievement in a customer service role with demonstration of meeting customer needs and concerns.

Education

• Minimum of a Bachelor’s degree or equivalent

We offer a competitive package that includes

We need Fluent English