Study Start-up Manager -Bangalore
On-site · Bengaluru, Karnataka, India
Job Summary
Start-Up leadership at country level for AstraZeneca’s clinical start-up activities in India (Bangalore), coordinating site activation, regulatory and ethics submissions, and ensuring study readiness. Responsibilities include coordinating document collection/review, submissions to regulatory authorities and IEC/IRBs, maintaining site documentation, updating CTMS/eTMF for ICH-GCP-aligned start-up processes, tracking performance metrics, proactive issue follow-up to protect timelines, cross-functional collaboration with CRAs and local study teams, providing progress updates to country leadership, and driving timely submission stewardship throughout the study duration. Desirable experience includes cross-therapeutic program support, process improvements to shorten start-up cycles, and ability to translate start-up data into actionable insights for stakeholders.
Required Qualifications
- Experience conducting study start-up activities at country and site levels focused on regulatory and ethics submissions
- Strong knowledge of ICH-GCP and relevant local regulations governing clinical studies
- Hands-on experience preparing, submitting, and tracking applications for Regulatory Authorities and IEC/IRBs
- Proficiency in handling essential documents and overseeing start-up progress data
- Practical experience updating CTMS and handling eTMF content during start-up
- Ability to collaborate with CRAs, Local Study Teams, and country leadership to meet start-up timelines
- Established expertise in the regulatory field related to clinical studies
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