Entry Level Clinical Data Management Job at Novotech
Looking to build a successful career in Clinical Data Management Jobs? Here’s an exciting opportunity from Novotech Jobs for the position of Clinical Data Programmer I (SDTM) in India. If you have experience in SDTM programming, SAS, CDISC standards, or clinical research data management, this role offers an excellent chance to work with a globally recognised CRO. Explore this latest Life Science Jobs opening and take the next step toward an exciting career in clinical research and regulatory data programming.
About Novotech
Novotech is a global full-service Contract Research Organisation (CRO) established in 1997. With over 30 offices across Asia-Pacific, Europe, and the United States, the company delivers high-quality clinical research, regulatory consulting, and scientific advisory services to pharmaceutical and biotechnology companies worldwide. Novotech is known for its innovative work culture, employee-focused benefits, and commitment to advancing healthcare through clinical research excellence.
Job Details:
- Job Title: Clinical Data Programmer I (SDTM)
- Job Identification: 4181
- Job Schedule: Full time
- Locations: Ground Floor, Unit 1, Block E, Helios Business Park., Bangalore, 560103, IN
Position Overview
The Clinical Data Programmer I (SDTM) is responsible for developing, validating, and maintaining Study Data Tabulation Model (SDTM) datasets in accordance with clinical protocols, electronic Case Report Forms (eCRFs), Statistical Analysis Plans (SAPs), and CDISC standards. The role involves close collaboration with biostatisticians, statistical programmers, and cross-functional stakeholders to deliver high-quality, regulatory-compliant clinical datasets for analysis and submission.
Key Responsibilities
- Performs SDTM programming based on clinical protocols, eCRFs, and Statistical Analysis Plans.
- Develops and annotates SDTM Case Report Forms (CRFs).
- Programs and validates SDTM datasets from raw clinical data.
- Conducts SDTM quality control activities, including double programming and peer reviews.
- Prepares regulatory submission deliverables, including Define.xml, Reviewer’s Guides, and supporting documentation.
- Ensures compliance with company statistical programming standards, CDISC guidelines, and regulatory requirements.
- Documents SAS programs thoroughly to ensure traceability and maintainability.
- Validates SAS datasets using Pinnacle 21.
- Maintains study documentation, programming files, and project records.
- Completes timesheets and participates in departmental meetings and project discussions.
Required Qualifications
- Bachelor’s degree in Life Sciences, or another quantitative discipline.
- Strong understanding of SDTM programming concepts.
- Knowledge of Clinical Protocols and Statistical Analysis Plans.
- Effective organizational and documentation skills.
Required Experience
- 6 months to 2 years of experience in the pharmaceutical industry, Contract Research Organization (CRO), or a related clinical research environment.
- Hands-on experience with SDTM dataset development and implementation.
Technical Skills
- Proficiency in SAS programming for SDTM dataset creation, validation, and reporting.
- Strong knowledge of CDISC standards, including SDTM, SDTMIG, and Controlled Terminology.
- Familiarity with R programming for SDTM dataset generation and automation.
- Experience with Pinnacle 21 for SDTM validation.
- Understanding of clinical trial data, including study protocols, laboratory data, adverse events, and regulatory submission requirements.
Core Competencies
- Strong analytical and problem-solving abilities.
- High attention to detail with a focus on data quality and regulatory compliance.
- Effective collaboration and communication skills.
- Ability to manage multiple priorities while maintaining accuracy.
- Commitment to documentation standards and continuous quality improvement.
