Study Start Up Submissions Manager
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Job Description
Study Start up Submissions Manager managing regulatory submissions in clinical research for remote-based role in India. Overseeing regional APAC start-up and interactions with regulatory agencies.
Responsibilities:
- To perform close follow up of Clinical Trials submitted to Drugs Controller General of India (DCGI), Face to face visits expected.
- Facilitate meetings with DCGI, support consultation processes when needed.
- Efficiently manage and successfully execute all aspects of local and Regional APAC start-up;
- Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum CDSCO and DCGI).
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
- Present during bid defenses, general capabilities meetings, and audits.
Requirements:
- Bachelor’s degree and more than 8 years of regulatory submissions experience in clinical research, preferably with a CRO.
- Experience may include CRA or project management experience.
- Strong Local experience mandatory for RSC level.
- Local and Regional APAC experience mandatory for RSM level.
- Strong oral and written communication skills.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to EC and RA; including formulating responses to queries.
Benefits:
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
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