Job Title: Associate Director - Clinical Data Standards
Job ID: REQ-10022081
Location: Mumbai, India
Company: Novartis Healthcare Private Limited
About the Role
The Associate Director - Clinical Data Standards will play a crucial role in advising and leading the planning, development, and implementation of clinical data standards. These standards must comply with industry regulations (CDISC, regulatory guidelines) and ensure high-quality data management in clinical trials. The role will involve driving the implementation of clinical data standards, infrastructure, and automation technologies, ensuring alignment with the Clinical Data Standards (CDS) strategy.
Key Responsibilities
Clinical Data Standards Development:
Lead the planning, definition, development, validation, and support of clinical data standards and automation solutions.
Drive the efficient and timely implementation of new standards, tools, and technologies.
Project Management and Leadership:
Serve as the primary contact for global therapeutic area (TA) data standards, ensuring that deliverables are met on time and meet quality expectations.
Provide leadership and contribute to the development, maintenance, and training on relevant clinical standards systems and processes.
Cross-Functional Collaboration:
Collaborate with global teams and stakeholders, including Clinical Development, Biostatistics, and Data Operations, to implement standards and technologies effectively.
Act as a subject matter expert (SME) in clinical data standards, supporting the development and implementation of tools in electronic data capture (EDC), database programming, metadata management, and more.
Governance and Compliance:
Oversee the governance and approval of clinical data standards and technologies, ensuring they align with industry regulations.
Lead technical reviews and assessments of regulatory standards, supporting gap analysis and implementation of action plans.
Mentoring and Talent Development:
Provide mentoring and technical guidance to Clinical Data Standards associates.
Contribute to the development of talent within the organization.
Key Performance Indicators
Timely execution of projects and data requests.
Positive feedback from project sponsors and key stakeholders.
Adherence to Novartis policies, guidelines, and KPIs.
Minimum Requirements
Education:
A degree in Computer Science, Biostatistics, Clinical Trials, Data Analytics, or a related field.
Experience:
Proven experience in clinical data standards, including CDISC (e.g., CDASH, SDTM, ADaM).
Hands-on experience with clinical data management, EDC systems, and automation technologies.
Project management experience and the ability to work in cross-functional teams.
Skills:
Strong problem-solving and decision-making skills.
Expertise in automation, biostatistics, clinical trials, metadata management, and statistical analysis.
Excellent communication and collaboration skills, especially in a cross-functional environment.
Why Novartis?
At Novartis, we’re driven by the desire to improve lives through innovative science. By joining Novartis, you’ll be part of a team that is passionate about breakthroughs that change patients' lives.
Diversity & Inclusion: Novartis is dedicated to fostering an inclusive environment and diverse teams.
Benefits & Rewards: Learn more about the benefits and rewards.
How to Apply
To apply for this role, visit the Novartis Career Portal.
Additional Information
Accessibility: If you require accommodations due to a medical condition or disability, please contact diversityandincl.india@novartis.com.
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