Job Description:Department: Clinical AffairsRole: Clinical Data ManagementJob Location: Corporate Office, AhmedabadExperience Required: 2–5 YearsQualification: M.Sc. / B.Pharm. / M.Pharm. (Life Sciences / Clinical Research / Pharmacology / Pharmaceutics) Role Objective:A Clinical Data Management Specialist will support clinical studies by managing clinical data collection tools, data management documentation, data review, query handling, validation, and documentation activities while ensuring compliance with approved study protocols, company SOPs, GCP guidelines, and applicable regulatory requirements. Desired Candidate Profile:Education: B.Pharm/M.Pharm, M.Sc. in life sciences/clinical research, or any relevant qualification in clinical research, pharmacy, life sciences, or a healthcare-related discipline.Experience: 2-5 years of relevant experience in clinical data management, clinical research, clinical affairs, CRO/site data coordination, eCRF/CRF handling, or clinical documentation activities.Skills: Working understanding of clinical study protocols, CRFs/eCRFs, data management plans, data review, query generation and resolution, data validation, SOP documentation, and clinical trial documentation requirements.Attributes: Detail-oriented, ethical, disciplined in documentation, proactive in follow-up, able to coordinate with cross-functional teams, and committed to timelines, data quality, and confidentiality. Role & Responsibilities:Assist in the design and development of data collection tools, including Case Report Forms (CRFs) and Electronic CRFs (eCRFs), ensuring all CRFs are aligned with and developed as per the finalized study protocols.Support the preparation and maintenance of Data Management Plans (DMPs) outlining data handling procedures, data flow, validation requirements, query management processes, and documentation expectations for clinical studies.Perform routine clinical data review to identify discrepancies, inconsistencies, missing data, protocol deviations impacting data, or data quality concerns, and assist in timely query generation and resolution.Ensure data accuracy, completeness, and consistency through data validation, verification, reconciliation support, and basic quality control activities as per study requirements.Assist in the development, review, revision, and updating of Data Management Standard Operating Procedures (SOPs), work instructions, templates, and related documentation as required.Provide data management inputs and operational support for ongoing clinical projects while coordinating with Clinical Affairs, Clinical Operations, Regulatory, QA, Biostatistics, Medical Writing, vendors, investigators, and site teams as applicable.Maintain proper clinical data management documentation, trackers, query logs, version-controlled study documents, and audit-ready records in line with company procedures and applicable guidelines.Ensure clinical data management activities are performed in compliance with approved protocols, GCP, company SOPs, applicable regulatory requirements, and internal quality standards.Support CRF/eCRF review, data entry checks, edit check review, database testing/UAT support, data cleaning activities, and database lock readiness activities as applicable to the assigned study.Track pending data, open queries, and missing forms/documents and follow up with relevant stakeholders to ensure timely completion of data management deliverables.Identify, escalate, and support resolution of data-related issues in a timely manner to avoid impact on study timelines and data integrity.Perform other clinical data management and clinical affairs-related duties as assigned by the reporting manager. Functional Skills Required:Good understanding of clinical trial/clinical investigation processes and clinical study life cycle from study start-up to database lock/close-out.Knowledge of CRF/eCRF design principles, data collection requirements, edit checks, query management, data cleaning, validation, and clinical data review processes.Understanding of Data Management Plans, SOPs, work instructions, controlled documents, clinical study protocols, source documents, and clinical data standards.Familiarity with GCP requirements, company procedure compliance, data confidentiality, ALCOA+ principles, and audit-ready documentation practices.Ability to maintain trackers, query logs, data review records, version history, and follow-up documents accurately and within timelines.Good working knowledge of MS Office tools such as Word, Excel, PowerPoint, and Outlook; exposure to EDC/eCRF systems will be an added advantage. Behavioral Skills Required:Strong written and verbal communication skills with professional etiquette while interacting with internal teams, vendors, investigators, site staff, and cross-functional stakeholders.High attention to detail, documentation discipline, accuracy orientation, and commitment to data quality and timelines.Ability to prioritize tasks, follow up effectively, and manage multiple study-related activities under guidance or independently as per role level.Problem-solving mindset with ability to identify data-related issues early and escalate appropriately.Integrity, confidentiality, teamwork, adaptability, ownership, and willingness to learn new clinical data management systems and processes. Team Size to be Handled:Reports to: AGM – Clinical AffairsTeam Structure: Individual contributor role Important Links:Website: https://biotechhealthcare.com/LinkedIn: https://www.linkedin.com/company/biotechhealthcare/Instagram: Biotech Vision Care Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.