Clinical Data Management Associate II

This is a fully remote position, open to applicants in India.

📋 Description

• Evaluate study documentation and project requirements to determine their impact on Clinical Data Management processes, standards, and deliverables.

• Collaborate with interdisciplinary teams to facilitate study setup, data collection strategies, and adapting project requirements.

• Assist in the implementation and execution of data management plans for designated imaging studies.

• Define, implement, review, and maintain edit checks to detect discrepancies and ensure the integrity of clinical data.

• Analyze clinical and imaging-related data to pinpoint inconsistencies, trends, and issues related to data quality.

• Develop and sustain study data specifications, encompassing data transfer specifications, system configuration specifications, and data validation criteria.

• Create, review, and maintain transmittal forms and study documentation, ensuring adherence to established standards.

• Investigate and address data discrepancies and unresolved issues in collaboration with project teams.

• Monitor data-related issues until resolution and ensure timely communication with relevant stakeholders.

• Prepare, validate, and provide ad hoc data listings and study reports.

• Identify opportunities for system enhancements, bugs, or process improvements and facilitate communication with Product Management teams.

• Maintain complete, accurate, and audit-ready study documentation throughout the study lifecycle.

• Communicate project status, risks, and data quality issues to supervisors and project stakeholders.

• Contribute to departmental initiatives for process improvement, updates to SOPs, and quality enhancement efforts.

• Ensure compliance with company procedures, Good Clinical Practice standards, and relevant regulatory expectations.

⛳️ Requirements

• Preferred: Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related field, or equivalent professional experience.

• At least 3 years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceuticals, CRO, or similar healthcare settings.

• Understanding of clinical trial processes, data review methodologies, and principles of clinical database management.

• Familiarity with relational database concepts, data validation techniques, and quality control processes.

• Preferred experience in developing or maintaining data specifications, edit checks, data transfer requirements, or study configuration documentation.

• Knowledge of clinical trial terminology and experience in regulated research environments.

• Proficient in Microsoft Office applications, including Word, Excel, Access, Outlook, and PowerPoint.

• Strong analytical and problem-solving abilities to identify and resolve data quality issues.

• Meticulous attention to detail and a commitment to data accuracy and quality.

• Excellent organizational, documentation, and time-management capabilities.

• Strong verbal and written communication skills, with the ability to communicate effectively in English.

• Capability to work independently while effectively collaborating within cross-functional and global teams.

• A professional, proactive, and customer-oriented approach with a focus on continuous improvement.

🏝️ Benefits

• Competitive pay and incentives.

• Provident fund and medical insurance.

• Engaging employee programs and local events.

• Modern office environments and flexibility for remote work.

• Opportunities for professional growth and career advancement within a global organization.