TCS is hiring Clinical Data Coordinator /n Location – Mumbai/Pune/Bangalore /n Roles &
Responsibilities /n • 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 /n • Performs data review of clinical trial data, including query management /n • Performs reconciliation review of external data against EDC data /n • May assist in creating study documents or assist in running study reports and metrics /n • Performs additional review activities for interim and final database locks as needed. Documentation & Filing /n • Files study documentation in electronic Trial Master File (eTMF) and department project files. /n • Performs periodic quality review of eTMF documents. /n • Assists with taking meeting minutes and documenting/tracking study data management activities. /n • Performs data archival activities. /n • 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 /n • Assists with quality review of above activities performed by the CRO, as needed.
/n • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. /n • Performs other duties as assigned.
Educational
Qualifications /n • Associate or bachelor's Degree preferred Experience /n • Ideally 6 or more years relevant work experience, or equivalent combination of training and experience. /n • Familiar with electronic data collection systems /n • Preferred knowledge of data management best practices & technologies as applied to clinical trials. /n • 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 /n • Good time management skills /n • Quick learner and comfortable learning new technologies and systems /n • Positive knowledge of office software (Microsoft Office).
Behavioral
Competencies /n • Is comfortable with ambiguity. /n • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Job Complexity /n • Low-Medium complexity project. /n • Occasional domestic/international travel to other sites, strategic partners, and therapeutic area events may be required. /n Regards /n Manisha Singh