Job Title: Associate Scientist – Clinical Unit (CRO)
Location: Pune, Maharashtra, India
Company: Lupin
Employment Type: Full-Time
About the Role:
Lupin is seeking an experienced Associate Scientist – Clinical Unit with 5–7 years of hands-on experience in clinical BA/BE studies, both outsourced and in-house. The role involves monitoring clinical trials at CROs, coordinating study activities, ensuring regulatory compliance, and managing clinical documentation throughout the study lifecycle.
Key Responsibilities:
Monitor outsourced clinical BA/BE studies at external CROs in compliance with study protocols and regulatory guidelines.
Coordinate with external CRO representatives for technical discussions, study updates, and query resolution.
Review Trial Master Files (TMF), screening MSRs, Informed Consent Documents (ICDs), periodic CRFs, dosing records, sample collection, and sample processing during monitoring visits.
Plan, execute, and supervise in-house BA/BE studies as a Clinical Research Coordinator (CRC).
Coordinate in-house studies from protocol training to TMF compilation, study planning, preparation of updates, and resolution of study-related queries.
Ensure accurate and complete documentation of raw data throughout all phases of the clinical study.
Required Experience & Skills:
5–7 years of relevant experience in clinical research, particularly in BA/BE study monitoring and coordination.
Strong knowledge of regulatory guidelines, Good Clinical Practice (GCP), and clinical trial protocols.
Proficiency in TMF management, CRF review, and study documentation.
Excellent coordination, communication, and problem-solving skills for internal teams and external CROs.
Education:
Master’s degree in Pharmacy (M.Pharm) or related discipline.
Postgraduate degree preferred.
Core Competencies:
Clinical study monitoring and coordination
Regulatory compliance and documentation accuracy
Team collaboration and stakeholder management
Analytical and problem-solving skills
Why Join Lupin:
Opportunity to work on both outsourced and in-house clinical BA/BE studies.
Engage with global CROs and cross-functional teams.
Build expertise in clinical trial execution, documentation, and regulatory compliance.
Gujarat :
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