Director CDM Inductive Quotient Analytics India

13.0 - 15.0 years

15 - 20 Lacs

Hyderabad

Work from Office

www.inductivequotient.com Director Clinical Data Management About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com Position: Clinical Data Management Director Requirement: Immediate Joiner Location: Hyderabad Mode: Work from office. Job description: We are seeking an experienced Director, Clinical Data Management with over 13 years of progressive experience in clinical data management within a CRO environment. The ideal candidate will lead the clinical data management team, oversee complex clinical trials, and ensure the delivery of high-quality, compliant data to support clinical development programs. Key Responsibilities: Provide strategic leadership and oversight to the clinical data management (CDM) team across multiple therapeutic areas and complex clinical trials. Develop and implement data management plans, standards, and procedures to ensure data quality, accuracy, and integrity. Collaborate closely with Clinical Operations, Biostatistics, Medical Writing, and Regulatory teams to support clinical trial planning and execution. Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory requirements governing clinical data management. Mentor, develop, and lead a team of data managers and coordinators, fostering a culture of continuous learning and professional development. Review and approve key data management deliverables such as Data Management Plans (DMP), CRF designs, data validation specifications, and study reports. Support audits and inspections conducted by regulatory authorities and clients. Act as a key point of contact for clients on data management-related matters, ensuring excellent customer service and communication. Contribute to business development activities, including proposal writing and client presentations. Lead the development and execution of data strategy to align with overall clinical development objectives and timelines. Oversee the integration of new technologies, such as AI and machine learning tools, to enhance data quality and efficiency. Establish and maintain key performance indicators (KPIs) and metrics to monitor the effectiveness and productivity of the data management function. Collaborate with IT and software development teams to customize and optimize clinical data systems and tools. Ensure timely resolution of data queries and discrepancies to minimize delays in database lock and study close-out. Drive data governance and data privacy initiatives to comply with GDPR, HIPAA, and other data protection regulations. Lead cross-functional risk assessments and implement mitigation strategies related to clinical data integrity. Represent the clinical data management function in leadership meetings and contribute to strategic planning. Support training programs for new hires and provide continuous education to the CDM team to keep pace with industry trends. Participate in post-study data review and contribute to the publication of clinical trial results. Document lessons learned and best practices to improve future studies. Manage timelines, budgets, and resource allocation for the clinical data management department. Drive process improvements and implement industry best practices and innovative technologies in data capture, validation, and reporting. Oversee vendor selection, management, and performance evaluation for external data management services and EDC providers. Qualifications: Bachelors degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred. Minimum of 13 years of clinical data management experience in a CRO or pharmaceutical setting. Proven leadership experience managing large teams and multiple projects simultaneously. Proficiency with EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical, Trial Master) and clinical data management tools. Deep knowledge of clinical trial processes, CDISC standards, and regulatory requirements (ICH-GCP, FDA, EMA). Strong project management skills, including budgeting and resource planning. Excellent communication, interpersonal, and client management skills. Ability to work effectively in a fast-paced, dynamic environment and drive cross-functional collaboration. Experience with risk-based monitoring and data quality initiatives is a plus. Maintain up-to-date knowledge of industry standards and regulatory requirements. Excellent organizational skills and ability to manage multiple projects simultaneously. Why Inductive Quotient? We are team a of 75 + talented and passionate professionals with strong statistical and analytical background combined with required study expertise. We IQians take lots of pride in our culture that enables open and creative thinking, deeply valuing our employees and their contributions towards our organization success.

Posted 1 month ago

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