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Trigent Software
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Study Start-up and Regulatory Submission Manager

Study Start-up and Regulatory Submission Manager

Trigent Software

5 - 10 years

6 - 12 Lacs

navi mumbai

Posted:1 week ago| Platform:

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Skills Required

dcgi cta clinical trials regulatory submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Location:

Experience Required:

Employment Type:

Working Days:

Study Start-up and Regulatory Submission Manager

Key Responsibilities:

Lead and manage
Clinical Trial Applications (CTA)
and
regulatory submissions
in compliance with Indian regulatory requirements.
Drive
clinical study start-up activities
, including site identification, feasibility, and activation.
Coordinate with
ethics committees and clinical trial sites
to ensure smooth and timely approvals.
Prepare, review, and submit study-related documents to
DCGI (Drug Controller General of India)
and other relevant authorities.
Ensure compliance with
ICH-GCP guidelines, local regulations, and company SOPs
throughout the process.
Collaborate with cross-functional teams to ensure on-time study initiation.

If you or someone you know fits this role, apply directly through the job post or share your resume at navya_b@trigent.com

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