Clinical Data Coordinator

TCS is hiring Clinical Data CoordinatorLocation – Mumbai/Pune/BangaloreRoles & 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• Good time management skills• Quick learner and comfortable learning new technologies and systems• Good knowledge of office software (Microsoft Office). Behavioral Competencies• Is comfortable with ambiguity.• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Job Complexity• Low-Medium complexity project.• Occasional domestic/international travel to other sites, strategic partners, and therapeutic area events may be required.RegardsManisha Singh