Study Start-Up Submissions Coordinator
Job Summary
Medpace is seeking a full-time, office-based Study Start-Up Submissions Coordinator to join our Clinical Operations team in Mumbai, India. This role is vital to our success and offers an exciting opportunity for individuals eager to apply their expertise while advancing their careers. Our culture fosters empowerment, allowing teams to leverage their unique talents to tackle challenges in research and problem-solving.
Responsibilities
Conduct activities essential for activating investigative sites in all phases of clinical trials.
Prepare, review, and submit regulatory documents to relevant authorities.
Communicate effectively with global study teams regarding study progress.
Identify and mitigate risks related to site activations.
Provide guidance on ethics and regulatory submissions to global study teams.
Review and finalize essential documents for site activation.
Serve as the primary contact for ethical and regulatory submission-related activities.
Maintain direct communication with investigative sites during the start-up and activation process.
Ensure submissions comply with relevant regulations and guidelines.
Advise sponsors on evolving regulations and compliance requirements.
Track submissions and ensure timely filing of documents.
Qualifications
Bachelor’s degree in a scientific field or equivalent combination of education and experience.
At least one year of relevant experience in a CRO, pharmaceutical company, or investigative site.
Excellent organizational and communication skills.
Proficiency in Microsoft® Office.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Hands-on experience preparing and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries.
Strong command of the English language.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing 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 a scientific and disciplined approach. With headquarters in Cincinnati, Ohio, and over 5,000 employees across 40+ countries, we leverage local regulatory and therapeutic expertise across various areas, including oncology, cardiology, metabolic disease, and more.
Why Medpace?
People. Purpose. Passion. Make a difference today for a better tomorrow. Our work over the past 30+ years has positively impacted countless patients and families facing numerous diseases. The work we do now will continue to improve lives in the future.
Medpace Perks
Hybrid work-from-home options (dependent on position and level).
Competitive PTO packages.
Company-sponsored employee appreciation events.
Employee health and wellness initiatives.
Flexible work schedules.
Competitive compensation and benefits package.
Structured career paths with opportunities for professional growth.
Awards
Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024, and has received CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
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