Clinical Data Coordinator

TCS is hiring Clinical Data Coordinator

Location – Mumbai/Pune/Bangalore

Roles & Responsibilities

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

Manisha Singh