Job Description 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 • Valuable time management skills
n • Quick learner and comfortable learning new technologies and systems
n • Good 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