Clinical Document Agent

Accountabilities:

• 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:

• 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.

Benefits:

• Opportunity to contribute to clinical research projects supporting the development of new therapies.

• Exposure to international clinical research operations and collaboration with global teams.

• Professional development opportunities through technical training and continuous learning.

• Supportive team environment focused on knowledge sharing and collaboration.

• Opportunities for career progression within a global life sciences and clinical research environment.

• Remote work arrangement for pre-approved locations.

• Full-time employment opportunity.

• Fixed working hours: 2:00 PM to 11:00 PM IST (second shift).