Study Start-up Manager -Bangalore
On-site · Bengaluru, Karnataka, India
Job Summary
Start-Up Manager leads country-level start-up operations for regulatory and ethics submissions across Indian sites, coordinating document preparation, submissions to regulatory authorities and IEC/IRBs, and ensuring site activation and study readiness. Responsibilities include managing site documentation, updating CTMS/eTMF content, monitoring start-up metrics, handling issue resolution, and collaborating with CRAs, Local Study Teams, and leadership to meet timelines while maintaining ICH-GCP-compliant quality. Desirable cross-functional experience across local/regional/global programs and a track record of improving start-up cycle times.
Required Qualifications
- Experience conducting study start-up activities at country and site levels
- Strong knowledge of ICH-GCP and 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
- Updating CTMS and eTMF content during start-up
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