Clinical Data Management Associate II

🔥 3 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

✨ Data Management

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• Review study documentation and project requirements to assess impacts on Clinical Data Management processes, standards, and deliverables • Collaborate with cross-functional teams to support study setup, data collection strategies, and evolving project requirements • Support implementation and execution of data management plans for assigned imaging studies • Define, execute, review, and maintain edit checks to identify discrepancies and ensure high-quality clinical data • Review clinical and imaging-related data to identify inconsistencies, trends, and data quality issues • Develop and maintain study data specifications, including data transfer specifications, system configuration specifications, and data validation requirements • Create, review, and maintain transmittal forms and study documentation while ensuring compliance with established standards • Investigate and resolve data discrepancies and outstanding issues with project teams • Track data-related issues through resolution and ensure timely follow-up with relevant stakeholders • Prepare, validate, and deliver ad hoc data listings and study reports • Identify system enhancements, bugs, or process improvement opportunities and coordinate communication with Product Management teams • Maintain complete, accurate, and audit-ready study documentation throughout the study lifecycle • Communicate project status, risks, and data quality concerns to supervisors and project stakeholders • Contribute to departmental process improvement initiatives, SOP updates, and quality enhancement activities • Support compliance with company procedures, Good Clinical Practice requirements, and applicable regulatory expectations

🎯 Requirements

• Bachelor's degree in Computer Science, Life Sciences, Healthcare, Clinical Research, Data Science, or a related field preferred, or equivalent professional experience • Minimum 3 or 3+ years of experience in Clinical Data Management, clinical research, biotechnology, pharmaceutical, CRO, or related healthcare environments • Understanding of clinical trial processes, data review methodologies, and clinical database management principles • Working knowledge of relational database concepts, data validation techniques, and quality control processes • Experience developing or maintaining data specifications, edit checks, data transfer requirements, or study configuration documentation preferred • Familiarity with clinical trial terminology and regulated research environments • Proficiency with Microsoft Office applications, including Word, Excel, Access, Outlook, and PowerPoint • Strong analytical and problem-solving skills with the ability to identify and resolve data quality issues • Excellent attention to detail and commitment to data accuracy and quality • Strong organizational, documentation, and time-management skills • Excellent verbal and written communication skills with the ability to communicate effectively in English • Ability to work independently while collaborating effectively within cross-functional and global teams • Professional, proactive, and customer-focused approach with a commitment to continuous improvement

🏖️ Benefits

• Competitive pay and incentives • Provident fund and medical insurance • Engaging employee programs and local events • Modern office spaces and remote work flexibility • Opportunities for professional growth and career development within a global organization

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