Clinical Operations Manager 2
On-site · Thāne, Maharashtra, India
Job Summary
Clinical Operations Manager 2 responsible for end-to-end operational support across the lifecycle of Phase I-IV studies, ensuring efficiency, compliance, and quality. Tasks include managing electronic Trial Master File (eTMF) quality and administration (Veeva, EDL), user access, and document preparation; coordinating translation, SUSAR translation, scanning, printing, and stamping; serving as local archiving coordinator; developing study metrics and quality reporting; coordinating study supplies, IMP returns, and destruction documentation; providing financial and payment support, PO creation, and procurement assistance; supporting compliance processes (HCP creation, investigator meetings, external payments); coordinating local posting in line with APAC requirements; driving process optimization; handling post-site close-out activities (EOSPDF); and assisting with interviewing and mentoring Clinical Operations Specialists/Experts. Requires a healthcare-related bachelor’s degree, 5+ years in clinical operations or healthcare/pharma, strong knowledge of ICH-GCP, English proficiency with Japanese/Korean a plus, independent work capability, and adaptability to ambigious/collaborative environments.
Required Qualifications
- Healthcare related Bachelor’s degree or equivalent
- 5+ years of experience in clinical operations or healthcare/pharmaceutical industry/clinical research
- Understanding of ICH-GCP and international regulations
- Professional-level English; Japanese and/or Korean a plus
- Ability to work independently, critical thinking, problem-solving
- Experience with eTMF systems (e.g., Veeva) and site start-up
- Knowledge of regulatory documentation, quality metrics, and compliance processes
- Experience with budgeting, payments, and procurement in a clinical operations context
- Ability to coordinate local posting and alignment with regulatory requirements
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