Offer summary

Qualifications:

Bachelor’s degree with over 8 years of regulatory submissions experience in clinical research, preferably with a CRO., Strong local and regional APAC experience is mandatory for the role., Excellent oral and written communication skills are essential., Hands-on experience in preparing, reviewing, and submitting regulatory documentation is required..

Key responsabilities:

Perform close follow-up of Clinical Trials submitted to the Drugs Controller General of India (DCGI).

Facilitate meetings with DCGI and support consultation processes as needed.

Manage and execute all aspects of local and regional APAC start-up independently.

Interact with sponsors, sites, IRBs/Ethics Committees, and regulatory agencies, while performing quality checks on submission documents.

Job description

We are currently seeking a full-time, remote-based Senior Study Start up Submissions Coordinator 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

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

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 Medpace?

People. 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 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 Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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