Clinical Trials Lead
2 weeks ago
Job Description
As a Clinical Trials Lead at Dr. Reddy's Laboratories Limited, you will be responsible for the preparation and review of critical documents related to clinical trials. Your expertise in clinical pharmacology and regulatory affairs will be crucial in ensuring compliance with regulatory requirements and guidelines.
Key Responsibilities
- Preparation and review of protocol, ICF, CSR documents
- Development and review of IB and clinical modules
- Coding review for AE/SAE, concomitant/prior drug, etc.
- Presence and presentation during investigator meetings, medical monitoring plan preparation, CRF review, and resolution of site queries
- Review of TLF, input for PD plan preparation, and decision-making
- Regulatory interactions and support for IRB and site queries
- Protocol training for the team
- Safety management plan review, regulatory submission narrative review, SAE follow-up, and facilitation of site interactions
- Review of DSUR, Annual Study Update, Medical review of ICSRs, Case narratives, Medical Review Manual, PSURs, RMPs, and Medical assessments of ICSRs
- PVG regulatory safety document review
- Therapeutic Area Expert (TAE) Meeting- Identify and connect with TAEs, hold successful meetings enabling sound medical/clinical discussions
- Medical support for all project-related work as and when required and delegated
Qualifications
MBBS, MD/DM Clinical Pharmacology or other paraclinical/clinical specialities, with at least 2-3 years of industry experience
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