Clinical Data Coordinator

Job description

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 • 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. Regards Manisha Singh