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).