Study Start up Submissions Manager

Efficiently manage and successfully execute all aspects of local and global start-up; Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum 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. We are currently seeking a full-time, office-based Study Start up Submissions Manager to join our Clinical Operations team in India, Mumbai. Responsibilities Efficiently manage and successfully execute all aspects of local and global start-up; Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum 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; Local and Regional experience will be highly advantageous; and Strong oral and written communication skills. Medpace 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. Why MedpacePeople. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks 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 Awards Recognized by Forbes as one of Americas Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets