Job Title: Clinical Transparency Specialist
Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad, Telangana, India
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Employment Type: Full-time, Regular
Shift Work: No
About the Role
The Clinical Transparency Specialist will support Novartis’ global cross-functional Transparency Submission Team to ensure timely, high-quality delivery of clinical trial transparency submissions. This role involves collaborating across functions, managing clinical trial data and documentation, and contributing to continuous process improvement initiatives.
Key Responsibilities
Transparency Submission Support:
Support the global cross-functional team to deliver clinical transparency submission documents in line with timelines, quality standards, operational and technical procedures.
Attend Transparency Submission planning meetings to support content definition.
Pre-submission Activities:
Contribute to Health Authority Transparency In-Scope Document books.
Apply lessons learned and identify potential efficiencies from previous submissions.
Team Collaboration:
Attend Transparency Submission Team meetings to track deliverable timelines in accordance with Novartis processes.
Contribute to continuous improvement and knowledge sharing through cross-functional lessons learned sessions.
Data Handling and Quality Control:
Perform marking, redaction, and anonymization of clinical trial documentation using appropriate tools.
Transfer encrypted raw and analysis data securely via Intralinks or similar tools and perform Acceptance Testing.
Complete QC on vendor and Novartis deliverables for assigned projects.
Migrate anonymized datasets to the Global Platform System (GPS).
Publishing and Archiving:
Support publishing, posting, and archiving of clinical trial documentation and datasets for disclosure.
Work with Transparency Management to track Health Authority requirements for clinical trial data sharing.
Key Performance Indicators (KPIs)
Quality and timely delivery of shared documents and datasets.
Effective execution of transparency strategies across clinical trial sharing initiatives.
Minimum Requirements
Work Experience:
5+ years in the pharmaceutical industry with broad understanding of the drug development process.
Knowledge of clinical trial transparency and data management.
Understanding of emerging principles and guidelines governing clinical trial transparency.
Awareness of the steps, roles, and responsibilities in generating clinical trial documentation, datasets, and submissions.
Experience in process improvement initiatives.
Skills and Competencies:
Critical and innovative thinking with pragmatic problem-solving skills.
Detail-oriented with a strong focus on quality.
Good interpersonal and communication skills (verbal and written), bridging scientific and business needs.
Knowledge of data privacy principles.
Why Novartis?
Helping people with disease and their families requires more than innovative science—it takes a community of smart, passionate people. At Novartis, we collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives.
Learn about Novartis’ strategy, people, and culture: Novartis About
Join our talent community: Novartis Talent Network
Explore benefits and rewards: Novartis Careers
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process or to perform essential functions of the role, please email: diversityandincl.india@novartis.com. Include your requisition number and contact information.
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