Novartis is a global healthcare leader known for its dedication to reimagining medicine and extending life expectancy through innovative research, development, and distribution of high-quality therapies. With a presence in over 150 countries, Novartis blends cutting-edge science with technological innovation to improve global health outcomes. The company prioritizes fostering a collaborative and inclusive environment that empowers employees to contribute to groundbreaking medical advancements.
Job Overview: Clinical Scientific Expert I
Novartis is seeking a Clinical Scientific Expert I to play a pivotal role in supporting clinical trial phases and ensuring data quality and compliance. This position, located in India, is essential for managing global clinical trial activities, upholding high standards, and contributing to strategic planning and execution.
Responsibilities in the Job
The Clinical Scientific Expert I is entrusted with comprehensive responsibilities that span various phases of clinical trials:
- Data Review & Quality Assurance: Ensure the highest quality of clinical trial data review and perform detailed analysis at the patient level. Identify trends, insights, and risks related to trial endpoints and patient safety.
- Support Clinical Trial Teams (CTT): Act as a core member of the CTT, supporting the Integrated Clinical Trial Team (iCTT) in all trial phases, including interim analysis, database activities, and post-lock assessments.
- Protocol Implementation: Collaborate on the development of the Data Review/Quality Plan (DRP/DQP) and strategy. Ensure consistent implementation of protocol elements, including deviations, eligibility criteria, and study assessments.
- Data Review and CRF Development: Work alongside line functions to develop Case Report Forms (CRFs) and ensure seamless data capture.
- Continuous Improvement Initiatives: Lead data review process improvements, including identifying and eliminating redundant reports and leveraging innovative data analysis tools.
- Regulatory Support: Contribute to study-level documents, such as Investigator’s Brochures, safety updates, and submission dossiers, ensuring compliance with regulatory requirements.
- Training & Development: Create and deliver training materials to the iCTT, promoting a culture of continuous learning and high performance.
Qualification Requirements
The ideal candidate should meet the following criteria:
- Educational Background: Advanced degree in life sciences or healthcare, such as a Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, or MD, is highly preferred.
- Experience: A minimum of 1 year of relevant experience in the pharmaceutical industry or clinical research organization. Basic knowledge in planning, executing, and reporting on global clinical studies.
- Clinical Operations Experience: Preferable work experience in clinical operations.
- Language Proficiency: Fluent in English (both oral and written).
Key Skills
The role requires a well-rounded skill set, including:
- Interpersonal Abilities: Strong negotiation and conflict resolution skills, with a proven ability to collaborate across boundaries.
- Problem-Solving: Ability to resolve issues independently and escalate when necessary.
- Technical Proficiency: Solid understanding of Good Clinical Practice (GCP), clinical trial design, statistical analysis, and the regulatory landscape.
- Analytical Skills: Strong background in analyzing data, interpreting trends, and drawing actionable insights.
- Medical Writing: Demonstrated competence in scientific writing for clinical documents and reports.
- Training & Development: Ability to produce educational materials and effectively train team members.
