Clinical Development Scientist

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Novartis Healthcare Private Limited in Hyderabad seeks a Clinical Scientific Expert I to support clinical trial activities and deliver data-driven insights under oversight. You will contribute to data review, safety assessments, and the preparation of study documentation while collaborating with global teams.

The role emphasizes data quality, regulatory compliance, and ongoing learning across trial phases. A relevant advanced degree and experience in clinical studies are preferred.

Qualifications

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
• Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• 1–2 years scientific, strategic and operational experience in planning, executing, reporting, and publishing clinical studies, or 3–4 years in Clinical Operations/Clinical Scientific role.
• Knowledge of Good Clinical Practice and drug development processes.
• Ability to collaborate across boundaries and elevate issues when needed.

Responsibilities

• Perform high quality clinical data review and identify insights from patient-level review.
• Support Interim Analysis, Database and Post Lock activities, and resolve data issues.
• Collaborate with line functions to improve data quality, safety, and eligibility assessments.
• Contribute to data review strategy and documentation such as DRP/DQP and CSR materials.
• Assist pharmacovigilance activities and training, as required.
• Present at study level meetings and develop subject matter expertise in disease areas.

Skills

Clinical Research

Clinical Trials

Data Integrity

Learning Design

Risk Monitoring

Education

Advanced degree in life sciences/healthcare (or clinically relevant degree)

Master's, PharmD, MPharm, PhD, MBBS, BDS, MD

Tools

Rave

OC-RDC

Job description

Job Description Summary

Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team.

Applicable to Clinical Scientific Expert I

The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.

Job Description Major Accountabilities

Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review. Contribute to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools. Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools. May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigators Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications. May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT. Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required. Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes). Contribute to line function initiatives, local and/or global education and process development projects, as required.

Essential Requirements

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.


• Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.


• 1-2 years scientific, strategic and operational experience in planning, executing, reporting, and publishing clinical studies in industry or Academia, or 3-4 years in Clinical Operations/Clinical Scientific role.


• Intermediate knowledge of planning, executing, reporting, and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution.


• Good knowledge of Good Clinical Practice and drug development processes.


• Strong scientific knowledge in at least one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes).


• Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting.


• Experience in Rave and/or OC-RDC is an advantage.


• Analytical / computational background; ability to detect data trends and elevate as appropriate.


• Demonstrates knowledge and application of statistical analysis methodology and good medical / scientific writing skills.


• Ability to collaborate across boundaries for shared success and resolve issues or understand when to elevate.

Skills Desired

• Clinical Research


• Clinical Trials


• Data Integrity


• Learning Design


• Risk Monitoring

Company Culture

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.