Hyderabad, Telangana, India
Onsite
Job Description Summary
-Accountable for managing all Data Mgmt / CDDRA deliverables for one or more assigned projects. Direct, oversee and coordinate all activities, deliverables and manage optimal use of resources within respective group or disease area. This is a key leader position ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deleiverables. It is a leader role with a strong understanding of the drug development process with a track record of agile/lean process development and training strategy and delivery for end-to-end deliverables in data Mgmt and statistical programming. Follows and oversees Good Clinical Practices (GCP), data-handling procedures and guidelines, reporting and tracking relevant business measures/metrics; organizational budget Mgmt; resource Mgmt and vendor Mgmt. Work seamlessly with partner groups. Lead, contribute to and implement initiatives to establish and maintain Novartis Data Mgmt as best in class in the industry. Leads and manages the review of clinical research protocols, reports and statistical analysis plans.Lead DO in all sponsor related Audits and inspections. -Responsible for assessing and ensuring data and programming quality, process adherence, appropriate documentation, system compliance, Facilitate sharing of resources between groups inorder to meet company goals and objectives.
Job Description
Major accountabilities:
Minimum Requirements
Bachelor’s or advanced degree in Life Sciences, Pharmacy, Nursing, Computer Science, or a related discipline, with strong business and operational acumen.
12+ years of experience in Drug Development, including 8+ years within Clinical Data Operations or related clinical development functions, with a proven track record of leading complex, global initiatives.
Demonstrated expertise in stakeholder management, negotiation, and influencing, with the ability to drive alignment and outcomes across senior leaders, cross-functional teams, and external partners.
Strong understanding of clinical trial methodologies, GCP (Good Clinical Practice), regulatory requirements, and clinical development processes, enabling effective governance and risk management.
Proven leadership experience in driving transformation, operational excellence, portfolio governance, and organizational change, including the successful delivery of cross-functional strategic programs.
Exceptional communication, collaboration, and problem-solving skills, with the ability to anticipate risks, operate effectively in a global matrix environment, and lead teams through complexity and change.
Skills Desired
Clinical Data Management, Data Architecture Development, Data Governance, Data Management, Data Quality, Data Science, Drug Development, Master Data, People Management, Waterfall ModelWant to know if this job is worth applying to?