Study Start up Submissions Manager (Remote based in Delhi)

Medpace; India; Remote; USD 682 - 1,137; Full time

Benefits offered by this job

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

Job summary

An established industry player is seeking a full-time, remote-based Study Start-up Submissions Manager to join their Clinical Operations team in India. This role involves managing regulatory submissions for clinical trials, facilitating meetings with regulatory bodies, and ensuring compliance with local and regional regulations. The ideal candidate will have over 8 years of experience in clinical research and regulatory submissions, with strong communication skills and the ability to work independently. Join a forward-thinking organization that values expertise and offers opportunities for career advancement and professional growth.

Qualifications

• Over 8 years of regulatory submissions experience in clinical research.
• Strong local and regional APAC experience required.

Responsibilities

• Manage and execute all aspects of local and regional APAC start-up.
• Perform quality checks on submission documents and site essential documents.

Skills

Regulatory submissions experience

Project management experience

Strong oral and written communication skills

Problem-solving skills

Education

Bachelor’s degree

Job description

Job Summary

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

1. To perform close follow up of Clinical Trials submitted to Drugs Controller General of India (DCGI), Face to face visits expected.
2. Facilitate meetings with DCGI, support consultation processes when needed.
3. Efficiently manage and successfully execute all aspects of local and Regional APAC start-up.
4. Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and regulatory agencies (minimum CDSCO and DCGI).
5. Perform quality checks on submission documents and site essential documents.
6. Prepare and approve informed consent forms.
7. Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
8. Present during bid defenses, general capabilities meetings, and audits.

Qualifications

1. 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.
2. Strong Local experience mandatory for RSC level, Local and Regional APAC experience mandatory for RSM level.
3. Strong oral and written communication skills.
4. 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

1. Flexible work environment.
2. Competitive compensation and benefits package.
3. Competitive PTO packages.
4. Structured career paths with opportunities for professional growth.
5. Company-sponsored employee appreciation events.
6. Employee health and wellness initiatives.

Awards

1. Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024.
2. 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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