Job Description

Job SummaryWe are currently seeking a full-time, remote-based Study Start up Submissions Manager to join our Clinical Operations team in India, Delhi.Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.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

• Bachelorxe2x80x99s 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

Medpace OverviewMedpace 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 Medpace?People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.The work wexe2x80x99ve 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 America's 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 NextA 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

Medpace