Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Regulatory Submissions (Study Start-Up) Manager

Medpace
Medpace
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.