Innovaderm Research
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Pharmaceutical • Manufacturing
Supports clinical trial Trial Master File maintenance by reviewing and quality-controlling records, assigning metadata, resolving document queries, participating in quality reviews, tracking milestones, preparing metrics, and coordinating with study teams. The role requires clinical research experience, knowledge of GCP and applicable regulations, strong organization and attention to detail, and proficiency in Microsoft Word and Excel. This is a home-based position in India with occasional evening meetings.
Pharmaceutical • Manufacturing
Leads statistical programming for clinical trials, including annotated CRFs, SDTM and ADaM datasets, TLFs, define.xml files, reviewer guides, and regulatory submission packages. Reviews SAPs and TLF shells, supports data cleaning, validates deliverables using Pinnacle 21, applies SAS macros, and serves as lead or unblinded programmer for interim analyses, IDMCs, and randomization activities. The role also mentors junior programmers and contributes to programming standards and process improvements.