Clinical Scientific Expert 1

IN10 (FCRS = IN010) Novartis Healthcare Private Limited; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novartis Healthcare Private Limited seeks a Clinical Scientific Expert I to provide clinical and scientific support across study phases, ensuring data plausibility and analytics for trial endpoints and patient safety.

The role emphasizes high-quality data review, collaboration with cross-functional teams, DRP/DQP development, and potential pharmacovigilance support, with applicable regulatory writing and data tools usage.

Qualifications

• Advanced degree required; 1–2 years in clinical studies or 3–4 years in Clinical Operations
• Strong knowledge of GCP and drug development processes
• Experience with clinical data collection and reporting; ability to use data tools

Responsibilities

• Perform high quality clinical data review and identify insights across patient level data
• Collaborate with line functions to enhance data quality and patient safety
• Develop data review strategies and DRP/DQP; ensure protocol deviations are managed
• Support pharmacovigilance activities when required
• Present findings at study level meetings and contribute to study documentation

Skills

Clinical data review

Data analysis

GCP knowledge

Statistical analysis

Medical writing

Cross-functional collaboration

Education

Advanced life sciences degree (Master's/PhD etc.)

Tools

EDC systems

Excel

Rave

OC-RDC

Job description

Job Description Summary

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 Integrated Clinical Trial Team (iCTT) 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. Contributes 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 Investigator’s 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 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. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .