Clinical Data Coordinator

vueverse. · India

Position Summary

Under the direction of the Clinical Data Management (CDM) Lead, the Data Coordinator – Clinical Data Management performs tasks to support the clinical trial data management lifecycle from study start-up through database lock and study close-out.

Under the direction of the CDM Lead or delegate, the Data Coordinator – Clinical Data Management contributes to the successful conduct of clinical trials and to the delivery of high-quality and timely data, which are used in statistical analysis and subsequently submitted to regulatory authorities for product approvals.

Key Accountabilities

Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (Standard Operating Procedures) and processes.

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 the 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 the 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 the above activities performed by the CRO, as needed.
• Ensures 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 of relevant work experience, or an equivalent combination of training and experience.
• Familiar with electronic data collection systems.
• Preferred knowledge of data management best practices and technologies as applied to clinical trials.
• Preferred knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes.

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 Microsoft Office.

Behavioral Competencies

• Comfortable working in an ambiguous environment.
• Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills.

Job Complexity

• Low to medium complexity projects.
• Occasional domestic and international travel to other sites, strategic partners, and therapeutic area events may be required.