Clinical Data Coordinator

Tata Consultancy Services; Mumbai; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Tata Consultancy Services is seeking a CDM support professional in Mumbai to manage data review, reconciliation with EDC, and study reporting. You will prepare study documents, assist with database locks, and support inspection readiness for regulatory reviews.

Ideal candidates have 6+ years in data management, experience with electronic data capture systems, and knowledge of FDA/ICH standards. Strong attention to detail and time management are essential for success.

Qualifications

• Associate or bachelor's degree preferred.
• Ideally 6+ years of relevant work experience.
• Familiar with electronic data collection systems.
• Knowledge of data management best practices in clinical trials.
• Knowledge of FDA & ICH regulations and industry standards.

Responsibilities

• Data review of clinical trial data and query management.
• Reconciliation review of external data against EDC data.
• Assist in creating study documents or running study reports.
• Support interim and final database locks as needed.
• Documentation in eTMF and project files; inspection readiness.
• Assist with quality review of CRO outputs and ensure SOP adherence.

Skills

Data management

Attention to detail

Organizational skills

Time management

Learning agility

Microsoft Office

EDC systems

FDA & ICH knowledge

Communication

Education

Associate or Bachelor's degree in life sciences / health informatics / IT

Tools

Microsoft Office

EDC tools

Job description

• 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 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.