TCS is hiring Clinical Data Coordinator
Location – Mumbai/Pune/Bangalore
Roles & Responsibilities
• Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories: Data Review
• Performs data review of clinical trial data, including query management
• Performs reconciliation review of external data against EDC data
• May assist in creating study documents or assist in running study reports and metrics
• Performs additional review activities for interim and final database locks as needed. Documentation & Filing
• Files study documentation in electronic Trial Master File (eTMF) and department project files.
• Performs periodic quality review of eTMF documents.
• Assists with taking meeting minutes and documenting/tracking study data management activities.
• Performs data archival activities.
• Performs inspection readiness activities and supports CDM team during internal and regulatory inspections Data Collection Systems May support the set-up and testing of study data collection tools. Additional Activities
• Assists with quality review of above activities performed by the CRO, as needed.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Performs other duties as assigned. Educational Qualifications
• Associate or bachelor's Degree preferred Experience
• Ideally 6 or more years relevant work experience, or equivalent combination of training and experience.
• Familiar with electronic data collection systems
• Preferred knowledge of data management best practices & technologies as applied to clinical trials.
• Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Special Skills/Abilities • Strong attention to detail, and organizational skills
• Valuable time management skills
• Quick learner and comfortable learning new tec