JOB SUMMARY
The Scientist – Clinical Research will play a pivotal role in designing, managing, and executing clinical and preclinical studies to support product development and innovation. The role demands expertise in clinical trial management, regulatory compliance, statistical analysis, and scientific writing, with strong cross-functional collaboration to align research outcomes with business objectives.
KEY RESPONSIBILITIES
1. Clinical Trial Management
· Design study protocols, manage vendors, oversee statistical analysis, and ensure CTRI registration compliance.
2. Study Monitoring
· Supervise ongoing trials, ensure data integrity, and coordinate with site teams for smooth execution.
3. Data Analysis & Reporting
· Perform statistical analysis, prepare Clinical Study Reports (CSR), and contribute to manuscript writing.
4. Investigational Product (IP) Management
· Handle label formatting, randomization, raw material arrangement, and dispatch of IP to clinical sites.
5. Preclinical Research
· Design, monitor, and interpret in vitro, ex vivo, and in vivo studies to support mechanism-of-action, safety, and efficacy claims.
6. Scientific Writing
· Prepare manuscripts, conference abstracts, dossiers, technical reports, and support patent landscaping.
7. Cross-functional Support
· Collaborate with marketing and other teams to provide scientific inputs and align research outcomes with business goals.
8. Regulatory Compliance
· Ensure adherence to ICH-GCP, Schedule Y, AYUSH guidelines, Ethics Committee requirements, and applicable standards.
9. Ethics & Regulatory Submissions
· Coordinate submission of study documents to Ethics Committees, Regulatory Authorities, and CTRI.
10. Feasibility & Site Management
· Conduct feasibility assessments, support site selection, investigator engagement and training, budget tracking, and vendor evaluation.
11. Advanced Statistical Analysis
· Develop Statistical Analysis Plans (SAPs) and perform/oversee advanced statistical analyses using appropriate tools.
12. Literature & Evidence Review
· Conduct systematic literature reviews, evidence assessments, and competitive intelligence analyses.
13. Travel & Auditing
· Willing to travel, especially to study sites for monitoring and auditing activities.
SKILLS AND KNOWLEDGE
QUALIFICATIONS
· Master’s/Ph.D. in Pharmacology, Clinical Research, Biotechnology, or related field.
· 5–7 years of experience in clinical trial management, data analysis, and scientific writing.
· Excellent communication, documentation, and cross-functional collaboration skills.
KEY COMPETENCIES
· Analytical Mindset: Strong problem-solving and detail-oriented approach.
· Project Management: Ability to manage multiple projects simultaneously.
· Vendor Management: Strong organizational and vendor coordination skills.
· Scientific Curiosity: Passion for translational research and innovation.
Be a part of Arjuna Natural Pvt Ltd’s passionate and driven team, contributing to the growth and success of a globally recognized nutraceutical company. We are looking for individuals with strong interpersonal skills, attention to detail, and a passion for purchase. Join us and grow your career while supporting our journey towards organizational excellence.
Work Location: In person
