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Regulatory Submissions (Study Start-Up) Manager

5+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Study Start-Up Submissions Manager

Location: Melbourne, Australia
Department: Clinical Operations
Company: Medpace


Job Summary

We are seeking a Study Start-Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia. This full-time position focuses on managing and executing all global start-up processes with a commitment to quality and compliance.


Responsibilities

  • Oversee and execute all aspects of global study start-up activities efficiently.
  • Conduct quality checks on submission and site essential documents.
  • Prepare and approve Informed Consent Forms (ICFs).
  • Review regulations and develop proactive solutions to address start-up challenges.
  • Represent Medpace during bid defenses, general capabilities meetings, and audits.

Qualifications

  • 5+ years of clinical research experience, preferably within a CRO.
    • Experience as a Clinical Research Associate (CRA) or in project management is advantageous.
  • Regional experience is highly desirable.
  • Strong oral and written communication skills.
  • Travel: Minimal.

About Medpace

Medpace is a leading clinical contract research organization (CRO) specializing in Phase I-IV clinical development services for biotechnology, pharmaceutical, and medical device industries. With over 30 years of experience, we drive the development of safe and effective medical therapies. Headquartered in Cincinnati, Ohio, Medpace operates in 40+ countries and employs more than 5,000 professionals.


Why Medpace?

People. Purpose. Passion.

  • Impactful Work: Advance global healthcare and improve patients' lives.
  • Collaborative Environment: Join a supportive and innovative team.
  • Career Growth: Structured career paths with mentorship and opportunities for advancement.

Medpace Perks

  • Work-Life Balance: Flexible work environment.
  • Comprehensive Benefits: Competitive compensation and PTO packages.
  • Professional Development: Participate in employee appreciation events and health initiatives.
  • Recognition:
    • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
    • Received CRO Leadership Awards for expertise, quality, and reliability.

What to Expect Next

Once your application is reviewed, a Medpace team member will contact you if your qualifications align with the role.

Medpace is an Equal Opportunity Employer, committed to diversity and inclusion.