Clinical Data Coordinator

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