Study Start up Submissions Manager (Remote based in Delhi)
IN
International Careers
Req #: 11221
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. 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; and * Present during bid defenses, general capabilities meetings, and audits. Qualifications: * 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
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