Study Start up Submissions Coordinator Role at Medpace, Navi Mumbai

Study Start-Up Submissions Coordinator Navi Mumbai, India Site Activation & Maintenance Job Summary We are currently seeking a full-time, office-based study start-up submissions coordinator to join our clinical operations team in our Mumbai, India, office. This role is a vital part of the team's ability to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise to develop and grow your career even further, then this is the opportunity for you. Responsibilities

Perform the required activities within the country that lead to the activation of investigative sites in all phases of clinical trials.
Prepare, review, and submit to regulatory agencies.
Communicate with global study teams and personnel on study progress.
Ability to effectively identify risks to site activations and mitigate them as necessary.
Provide expertise and guidance to global study teams in ethics and regulatory submissions.
Review and finalise the essential documents required for site activation.
Act as the main contact for ethical and regulatory submission-related activities.
Direct contact with investigative sites during the study start-up and activation process.
Ensure submissions comply with applicable regulations and guidance documents.
Advise sponsors on changing regulations and compliance requirements.
Track submissions and ensure timely filing of documents.

Qualifications

Bachelor's degree in the science field or an equivalent combination of education and experience.
At least one year of relevant working experience at a CRO, pharmaceutical company, or investigative site.
Excellent organisation and communication skills.
Knowledge of Microsoft® Office, ICH-GCP guidelines, and regulatory guidelines.
Hands-on experience preparing, reviewing, and submitting regulatory documentation to ethics committees and regulatory agencies, including formulating responses to queries.
Good command of English.

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Study Start up Submissions Coordinator Role at Medpace, Navi Mumbai[/caption] 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 our 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. Headquarters 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 facing 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