This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Clinical Data Management Associate II based in India.
We are seeking a detail-oriented Clinical Data Management Associate II to support the quality, accuracy, and integrity of clinical trial data across medical imaging studies. In this role, you will contribute to the end-to-end management of clinical study data, ensuring that information is accurately collected, reviewed, validated, and maintained. You will collaborate with cross-functional teams, clinical research professionals, and project stakeholders to support study execution and data quality objectives. Your responsibilities will include developing validation checks, investigating data discrepancies, maintaining study documentation, and preparing data reports. Working within a global clinical research environment, you will help ensure compliance with industry standards, regulatory requirements, and Good Clinical Practice (GCP). This opportunity offers the chance to contribute to meaningful medical research and support the development of innovative therapies that improve patients' lives.
Accountabilities
- Clinical Data Management: Support the implementation and execution of clinical data management plans for assigned medical imaging studies, ensuring data collection and management activities meet project requirements.
- Study Documentation Review: Review study documentation, protocols, and project requirements to assess their impact on data management processes, standards, and deliverables.
- Data Validation & Quality Control: Define, develop, execute, review, and maintain edit checks to identify inconsistencies, discrepancies, and missing information while ensuring clinical data accuracy and completeness.
- Clinical Data Review: Analyze clinical and imaging-related datasets to identify data quality issues, trends, inconsistencies, and potential errors requiring investigation.
- Data Specifications & System Configuration: Develop and maintain study-specific documentation, including data transfer specifications, system configuration specifications, and data validation requirements.
- Cross-Functional Collaboration: Work closely with project teams and operational stakeholders to support study setup, data collection strategies, and changing project requirements.
- Issue Management & Resolution: Investigate data discrepancies, coordinate resolution activities, track outstanding issues, and ensure timely follow-up with relevant stakeholders.
- Reporting & Data Deliverables: Prepare, review, validate, and deliver ad hoc data listings, study reports, and other data-related outputs according to project requirements.
- Documentation & Compliance: Create and maintain transmittal forms, study documentation, and accurate audit-ready records throughout the clinical study lifecycle.
- System & Process Improvements: Identify system defects, bugs, and opportunities for enhancements, coordinating with Product Management and relevant technical teams to support improvements.
- Stakeholder Communication: Provide regular updates on project progress, data quality concerns, potential risks, and outstanding issues to supervisors and project stakeholders.
- Continuous Improvement: Contribute to departmental improvement initiatives, standard operating procedure (SOP) updates, and quality enhancement activities.
- Regulatory Compliance: Ensure data management activities follow internal procedures, Good Clinical Practice (GCP), and applicable regulatory and industry requirements.
Requirements
- Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related discipline, or equivalent professional experience.
- At least 3 years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceuticals, Contract Research Organizations (CROs), or related healthcare environments.
- Good understanding of clinical trial processes, clinical data review methodologies, and clinical database management principles.
- Working knowledge of relational database concepts, data validation techniques, and quality control methodologies.
- Experience developing or maintaining data specifications, edit checks, data transfer requirements, or clinical study configuration documentation is preferred.
- Familiarity with clinical research terminology, medical imaging data, and regulated research environments.
- Proficiency in Microsoft Office applications, particularly Word, Excel, Access, Outlook, and PowerPoint.
- Strong analytical and problem-solving abilities, with the capacity to investigate discrepancies and resolve complex data quality issues.
- Exceptional attention to detail and a strong commitment to maintaining data accuracy, consistency, and integrity.
- Excellent organizational, documentation, and time-management skills, with the ability to manage multiple priorities and deadlines.
- Strong written and verbal communication skills in English, including the ability to communicate technical and project-related information clearly.
- Ability to work independently, demonstrate initiative, and collaborate effectively with cross-functional and geographically distributed teams.
- A proactive, professional, and customer-focused approach, with a strong sense of accountability and commitment to continuous improvement.
- Ability to adapt to changing project requirements while maintaining high standards of quality and compliance.
Benefits
- Competitive compensation package and performance-related incentives.
- Provident fund benefits.
- Medical insurance coverage.
- Flexible remote working opportunities within India.
- Access to modern office facilities and collaborative working environments.
- Employee engagement programs and local team events.
- Professional development and continuous learning opportunities.
- Career growth opportunities within an international organization.
- Exposure to global clinical research projects and medical imaging technologies.
- Opportunity to contribute to clinical studies supporting the development of life-changing therapies.
- Collaborative and purpose-driven work environment focused on scientific innovation and improving patient outcomes.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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