Documents Specialist : Clinical Research

Job Description

Documentation Specialist in a clinical research organization Location: City: Hyderabad Department: Regulatory bodies / Quality Assurance / Ethics Committees Reports To: Head of Department Employment Type: Full-Time Gender: Male Job Summary: The Documentation Specialist is responsible for managing, organizing, and maintaining regulatory, clinical, and operational documents in compliance with applicable guidelines and company SOPs and license conditions. This role ensures accuracy, completeness, and timely availability of critical records to support audits, inspections, and operational continuity. Key Responsibilities: Develop, format, and maintain controlled documents (SOPs, protocols, study reports, manuals, etc.) Ensure version control and proper archiving of all documentation. Collaborate with cross-functional teams to obtain necessary approvals and implement document updates. Track and manage documentation workflows using electronic document management systems (EDMS). Prepare regulatory submissions and assist in compiling dossiers for regulatory bodies (e.g., CDSCO, DCGI, USFDA, EMA). Maintain master files for clinical studies and Ethics Committees (EC/IRB). Support internal and external audits by retrieving required documentation promptly. Conduct periodic document reviews and coordinate training record updates for SOP revisions. Maintain confidentiality and data integrity across all records and communication. Qualifications: Pharm-D or PG with Clinical Research Course. Minimum 2-3 years of experience in documentation, preferably in a healthcare, pharmaceutical, or CRO environment. Familiarity with GCP, ICH, and regulatory guidelines. Experience with EDMS (e.g., MasterControl, Veeva Vault) is an advantage. Excellent written and verbal communication skills. Strong attention to detail and organizational abilities. Great in coordination Preferred Skills: Knowledge of regulatory filing formats (e.g., eCTD); SUGAM PORTAL; SAE-Handling; conducting meetings and able to handle multiple clinets on daily basis. able to handle heterogeneric types of research proposals Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook). Ability to manage multiple priorities and meet deadlines. Experience in handling Ethics Committee or regulatory submissions is a plus. Job Types: Full-time, Fresher Pay: ₹18,883.04 - ₹21,319.24 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025