Location: Hyderabad
Industry Type: Pharma / Healthcare / Clinical Research
Division: Development
Business Unit: Innovative Medicines
Job ID: REQ-10020654
Application Deadline: 30th October 2024
About Novartis
Novartis is renowned for its exciting product pipeline, focusing on innovative medicines developed by a diverse, talented, and performance-driven team. This environment makes Novartis one of the most rewarding employers in the industry.
Position Overview
We are seeking a Clinical Scientific Expert I to join our Integrated Clinical Trial Team (iCTT). In this role, you will be responsible for ensuring high-quality clinical trial data review, analysis, and insights, contributing to the overall success of our clinical studies.
Key Responsibilities
- Conduct comprehensive clinical data reviews, identifying insights through patient-level review and trends analysis.
- Support interim analysis, database activities, and post-lock activities, facilitating the resolution of clinical data issues.
- Collaborate with relevant functions to enhance clinical data quality, emphasizing subject safety, data integrity, and trend identification.
- Contribute to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy.
- Assist in Case Report Form (CRF) development and implement data capture tools as needed.
- Identify and implement improvements in the data review process, including innovative data analysis methodologies.
- Support the development of key regulatory documents and clinical trial documents for study activities.
- Participate in pharmacovigilance activities as required, including reviewing aggregate reports and attending Safety Monitoring Meetings (SMT).
- Create training materials and deliver training to the iCTT.
Candidate Profile
- Education: Advanced degree in life sciences/healthcare (Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, MD preferred).
- Experience: More than 1 year of experience in the pharmaceutical industry or clinical research organization. Experience in clinical operations is preferable.
- Skills:
- Strong interpersonal skills and ability to work under pressure.
- Good negotiation and conflict resolution skills.
- Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory processes.
- Strong analytical and computational skills, with the ability to identify trends and effectively analyze, interpret, and report data.
- Demonstrated medical/scientific writing skills.
Fluency in English (oral and written) is required.
Why Join Novartis?
At Novartis, you’ll be part of a team that is driven by purpose, focused on making a meaningful impact on patients’ lives. You will have the opportunity to contribute to groundbreaking research and work alongside industry experts.
Apply Now to be part of a leading organization that values your expertise and fosters your professional growth!