5d ago

Clinical Document Agent

IndiaRemoteFull-timemid

Other

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Quick Summary

Overview

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Document Agent based in India.

Technical Tools

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The Clinical Document Agent will play an important role in supporting clinical research projects by preparing, reviewing, and maintaining accurate clinical trial documentation. This role focuses on transforming raw study data into structured electronic documents while ensuring compliance with established procedures and quality standards. You will contribute to the preparation of patient files, clinical documentation forms, and essential study records. Working closely with Clinical Study Managers and cross-functional teams, you will help ensure that documentation is complete, accurate, and delivered within project timelines. The position also involves document quality control, peer reviews, and coordination with global stakeholders. This is an excellent opportunity for a detail-oriented clinical documentation professional to contribute to clinical research and support the development of new treatments.

Prepare and manage subject files throughout clinical projects, including reviewing templates, checking documentation accuracy, meeting deadlines, and incorporating client feedback.
Create electronic clinical documentation forms and prepare source documentation using Microsoft Excel and other relevant tools.
Convert raw clinical study data into electronic formats while ensuring accuracy, consistency, and compliance with established procedures.
Review and validate clinical documentation before transcription, identifying and correcting errors to maintain high-quality records.
Calculate final blood volumes for study participants and verify that appropriate washout periods and dates are correctly documented.
Coordinate subject meal requirements throughout clinical studies, including ordering and follow-up activities.
Conduct peer reviews of team deliverables and support the identification and resolution of documentation-related issues.
Collaborate with Clinical Study Managers and internal and external stakeholders to obtain required documents and ensure timely project execution.
Support the onboarding and training of new team members by sharing documentation standards, processes, and best practices.
Ensure all activities comply with applicable corporate policies, standard operating procedures (SOPs), regulatory requirements, and operational guidelines.

Requirements

~1 min read

Bachelor's or Master's degree in Life Sciences or a related discipline.
1–3 years of relevant professional experience in clinical documentation, clinical research, or a related field.
Mandatory experience working on Phase I clinical trials.
Good understanding of clinical trial documentation, including Investigator Site Files (ISF).
Proven experience in document quality control (Document QC) and clinical documentation review.
Hands-on experience creating clinical forms and source documentation using Microsoft Excel.
Strong proficiency in Microsoft Office, particularly Word and Excel, with good general computer skills.
Familiarity with Adobe tools and electronic documentation processes.
Ability to interpret project requirements and translate them into accurate, structured clinical documentation.
Strong written and verbal English communication skills, with the ability to coordinate effectively with global and cross-functional teams.
Excellent attention to detail, organizational skills, problem-solving abilities, and time management.
Ability to work independently while collaborating effectively with colleagues and stakeholders.
Candidates with TMF Lead experience may also be considered.