Study Start up Submissions Manager (Remote based in Delhi)
Core
Manage clinical trial startup submissions to Indian regulatory agencies (DCGI/CDSCO) and facilitate face-to-face consultations.
Role type
Senior Clinical Operations Manager (Regulatory Submissions)
Builds
Regulatory submission packages and startup execution for clinical trials in India and APAC
Domain
Clinical Research / Regulatory Affairs / Life Sciences
Required skills
Regulatory submissions, DCGI/CDSCO interaction, IRB/EC management, document quality control, informed consent preparation, regional APAC experience, CRO experience
Preferred skills
CRA or project management experience
Technologies
None stated
Responsibilities
Follow up on clinical trial submissions to DCGI, facilitate meetings with regulatory agencies, manage local and Regional APAC startup execution, interact with sponsors and ethics committees, perform quality checks on submission documents, prepare informed consent forms, present at bid defenses and audits
Seniority
Senior, hands-on IC
