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    Study Start Up Submissions Coordinator

    Medpace
    2+ years
    Not Disclosed
    Mumbai
    10 Sept. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Summary

    We are seeking a full-time, office-based Study Start-Up Submissions Coordinator to join our Clinical Operations team in Mumbai, India. This role is essential to our success, enabling you to leverage your expertise while furthering your career in an exciting environment.

    At Medpace, we value expertise and empower our teams to use their unique talents to proactively engage in research and problem-solving. Our employees embody our core values, working diligently to meet high expectations. In return, we offer rewarding projects, opportunities for career advancement, and exposure to our international operations.

    Responsibilities

    • Execute activities necessary for the activation of investigative sites across all phases of clinical trials.
    • Prepare, review, and submit documents to regulatory agencies.
    • Maintain communication with global study teams regarding study progress.
    • Identify and mitigate risks to site activation.
    • Provide guidance to global study teams on ethics and regulatory submissions.
    • Review and finalize essential documents required for site activation.
    • Serve as the primary contact for ethical and regulatory submission activities.
    • Communicate directly with investigative sites during the study start-up and activation process.
    • Ensure submissions adhere to applicable regulations and guidelines.
    • Advise sponsors on evolving regulations and compliance requirements.
    • Track submissions to ensure timely filing of documents.

    Qualifications

    • Bachelor's degree in a science-related field or equivalent 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 in preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies, including formulating responses to queries.
    • Strong command of English.

    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. We leverage local regulatory and therapeutic expertise across key areas, including oncology, cardiology, metabolic diseases, endocrinology, CNS, and anti-infectives. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

    Why Medpace?

    People. Purpose. Passion. Make a difference tomorrow—join us today!

    Our work over the past 30+ years has positively impacted countless patients and families facing various diseases. The contributions we make today will enhance the lives of those living with illness in the future.

    Medpace Perks

    • Hybrid work-from-home options (depending 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

    Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024, and consistently honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

    Join Medpace and be a part of our mission to improve patient lives!

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