We 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

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;
Robust 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

Medp

📌 Study Start up Submissions Manager (India)
🏢 Medpace
📍 India