Medpace Mumbai Hiring: Study Start up Submissions Coordinator

Medpace Mumbai Hiring: Study Start up Submissions Coordinator
  • Full Time
  • Mumbai

Study Start up Submissions Coordinator Jobs at Medpace: Ignite Your Clinical Operations Career

Join Medpace, a leading full-service clinical contract research organization (CRO), on a journey of scientific discovery and disciplined development of medical therapeutics. With a global presence across 40+ countries, Medpace is dedicated to accelerating the development of safe and effective medical solutions. If you are passionate about clinical research and seeking an opportunity to grow your career, Medpace is the place for you.

Medpace Vacancies List

Position Title: Study Start up Submissions Coordinator

Location: TTC, Thane Belapur Road, India

Department: Clinical Operations

Job Type: Full-Time

Job Description

As a Study Start up Submissions Coordinator at Medpace, you will be an essential part of our Clinical Operations team in Mumbai, India. Your role involves performing critical activities within the country to activate investigative sites for clinical trials. If you thrive in a dynamic environment, excel at problem-solving, and are committed to supporting business partners, this is the opportunity you’ve been waiting for.

Responsibilities

  1. Activate Investigative Sites:
    • Perform activities leading to the activation of investigative sites in all phases of clinical trials.
  2. Regulatory Submissions:
    • Prepare, review, and submit regulatory documents to Regulatory Agencies.
  3. Global Communication:
    • Communicate with global study teams and personnel on study progress.
  4. Risk Identification and Mitigation:
    • Effectively identify risks to site activations and mitigate as necessary.
  5. Ethics and Regulatory Guidance:
    • Provide expertise and guidance to global study teams in ethics and regulatory submissions.
  6. Essential Document Review:
    • Review and finalize essential documents required for site activation.
  7. Main Contact for Submissions:
    • Act as the main contact for Ethical and Regulatory submission-related activities.
  8. Site Interaction:
    • Direct contact with investigative sites during the study start-up and activation process.
  9. Regulatory Compliance:
    • Ensure submissions comply with applicable regulations and guidance documents.
  10. Regulatory Advisory:
    • Advise sponsors on changing regulations and compliance requirements.
  11. Submission Tracking:
    • Track submissions and ensure timely filing of documents.

Qualifications

  • Bachelor’s degree in the science field or equivalent combination of education and experience.
  • At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site.
  • Excellent organization 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.
  • Good command of English.

How to Apply

To apply for the position of Study Start up Submissions Coordinator at Medpace.

Apply online

Important Information (In Tabular Form)

InformationDetails
Position TitleStudy Start up Submissions Coordinator
DepartmentClinical Operations
LocationTTC, Thane Belapur Road, India
Job TypeFull-Time
Email for Application Apply online

To apply for this job please visit careers.medpace.com.

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