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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: Singapore
Department: Clinical Operations
Company: Medpace


Job Summary

We are looking for an experienced Study Start-Up Submissions Manager to join our Clinical Operations team in Singapore. This full-time position focuses on ensuring efficient management and execution of all global study start-up processes while maintaining compliance and quality standards.


Responsibilities

  • Oversee and execute all aspects of global study start-up activities.
  • Conduct quality checks on submission documents and site essential documents.
  • Prepare and approve Informed Consent Forms (ICFs).
  • Stay informed on regulations, proactively addressing start-up challenges with innovative solutions.
  • Represent Medpace during bid defenses, general capabilities meetings, and audits.

Qualifications

  • 5+ years of clinical research experience, ideally within a CRO setting.
    • Previous roles as a Clinical Research Associate (CRA) or project management experience are a plus.
  • Regional experience is highly beneficial.
  • Strong verbal and written communication skills.
  • Travel: Minimal.

About Medpace

Medpace is a global leader in clinical contract research organization (CRO) services, specializing in Phase I-IV clinical development for biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, Medpace operates in 40+ countries, employing over 5,000 professionals. Our mission is to accelerate the development of safe, effective medical therapies that improve patients' lives.


Why Medpace?

People. Purpose. Passion.

  • Meaningful Impact: Contribute to advancing global healthcare.
  • Collaborative Culture: Join a supportive, innovative, and motivated team.
  • Growth Opportunities: Access structured career development and mentoring.

Medpace Perks

  • Flexible Work Environment: Promoting work-life balance.
  • Comprehensive Benefits: Competitive compensation and PTO packages.
  • Professional Development: Participate in health initiatives and employee appreciation events.
  • Recognition:
    • Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021–2024).
    • Recipient of 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.