Job Title: Lead - Clinical Data Management
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Company: Novartis Healthcare Private Limited
Employment Type: Full-time, Regular
Shift Work: No
Lead a community of approximately 20 Clinical Data Acquisition Specialists, Clinical Data Scientists, and Coding Specialists within the assigned Therapeutic Area (TA). Ensure adequate staffing, resource allocation, and talent retention while fostering employee engagement and career development. Collaborate with the Senior Group Head to achieve TA-specific goals and key performance indicators (KPIs). Partner with functional mentors to establish learning networks across Clinical Data Acquisition and Management (CDAM). Work seamlessly with partner groups and contribute to initiatives that establish Novartis Clinical Data Acquisition and Management as an industry leader.
Lead Data Management activities for high-priority and complex programs/projects.
Act as a local manager for global associates, providing supervision and functional guidance.
Manage staffing, hiring, attrition, and career development for the assigned community.
Facilitate the sharing of resources across teams to meet company objectives.
Ensure employee engagement and foster a high-performance culture.
Ensure full compliance with global regulatory requirements and internal business objectives.
Drive functional excellence by defining strategic goals and operating policies.
Develop, coordinate, and implement metrics for internal teams and external (CRO, FSP) resources.
Oversee quality control and audit readiness of all Data Management deliverables.
Represent Data Management at audits, Health Authority (HA) meetings, and external conferences.
Ensure adherence to company policies, industry standards, and regulatory guidelines.
Propose and implement new Standard Operating Procedures (SOPs), Novartis Implementation Procedures (NIPs), and Work Procedures (WPs) as needed.
Partner with Senior Group Head to align with community goals and KPIs (quality, cost, cycle-time, productivity).
Define and negotiate Service Level Agreements (SLAs) with partners.
Build and maintain effective cross-functional collaborations.
Mentor and develop leadership capabilities within the team.
Lead and support clinical and non-clinical special projects and initiatives.
Identify and implement solutions for operational challenges and process improvements.
Drive a quality and compliance culture within the organization.
Ensure appropriate handling of exceptions, deviations, and Corrective and Preventive Actions (CAPA).
Maintain advanced knowledge of industry software, reporting tools, and regulatory requirements.
Act as a key representative for Data Management in submission teams and project discussions.
Ensure data accuracy, reliability, and regulatory compliance.
Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
Oversee the distribution of marketing samples where applicable.
Achievement of high-quality, timely, cost-efficient Data Management deliverables.
No critical audit findings related to Data Management.
Effectiveness of participation in internal and external initiatives.
Successful recruitment, retention, and development of talent.
Efficient resource allocation and usage.
Adherence to Novartis policies, guidelines, and industry regulations.
Positive feedback from customers, partners, and project stakeholders.
Cross-cultural experience.
People leadership and team management.
Project management expertise.
Clinical Data Management.
Cross-functional team collaboration.
Data Architecture & Governance.
Data Management & Quality.
Data Science & Strategy.
Drug Development.
Master Data Management.
People & Project Management.
English (fluent, including specialized technical communication and report writing).
At Novartis, we go beyond innovative science to make a real impact on patients and their families. We foster a community of smart, passionate professionals who collaborate to achieve breakthroughs that change lives. Join us in creating a brighter future together.
Learn more about our culture and strategy: Novartis Strategy
Explore our benefits and rewards: Novartis Benefits Handbook
Join our talent network for future opportunities: Novartis Talent Community
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