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Director, Clinical Trial Management

5+ years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Remote 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 Title:Director, Clinical Trial Management

Location: Cincinnati, Ohio (Dallas, TX, Denver, CO, or Remote options available)
Job Type: Full-time


ABOUT MEDPACE

Medpace is a leading 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 disease, endocrinology, central nervous system, and anti-viral and anti-infective.
Headquartered in Cincinnati, Ohio, Medpace employs more than 5,000 people across 40+ countries.


JOB SUMMARY

Medpace is seeking an experienced Director, Clinical Trial Management (CTM) to join our team and oversee the day-to-day operations of clinical projects. This senior-level position will serve as the primary contact for sponsors, manage project timelines, and ensure deliverables are met within regulatory requirements. The role requires a high level of expertise in clinical trial management and leadership.


KEY RESPONSIBILITIES

Project Oversight & Accountability

  • Manage daily operations of assigned clinical projects, ensuring adherence to ICH/GCP guidelines, applicable laws, and regulations.
  • Act as the primary Sponsor contact for operational project-specific issues and study deliverables.
  • Ensure cross-functional oversight of internal project team members and their deliverables.
  • Provide input and feedback for project documents such as study protocols, data analysis plans, and final study reports.
  • Develop operational project plans, ensuring timelines and budget expectations are met.
  • Assess and manage risks, identifying mitigation strategies for project delivery.
  • Manage study vendors, overseeing quality and monitoring deliverables where applicable.

Leadership & Team Collaboration

  • Provide leadership and guidance to the clinical trial management team, including ensuring appropriate project-specific training for team members.
  • Foster collaboration across multidisciplinary teams to ensure the successful execution of clinical trials.

Vendor & Site Management

  • Oversee site quality and monitoring deliverables, ensuring compliance and data integrity throughout the study.
  • Coordinate and manage relationships with external stakeholders, including study vendors and clinical sites.

QUALIFICATIONS & EXPERIENCE

Education

  • Bachelor’s degree in a health-related field; an advanced degree (Master’s or PhD) is preferred.

Experience

  • 5+ years of experience as a Project/Clinical Trial Manager within a CRO.
  • Experience managing projects through Phases 1-4, with a preference for Phases 2-3 experience.
  • Bid defense experience to support business development efforts.
  • Experience in managing project timelines and ensuring the successful delivery of clinical trials.

Skills & Competencies

  • Strong leadership and communication skills, with the ability to manage and mentor project teams.
  • Excellent understanding of clinical trial management processes, regulations, and industry standards.
  • Problem-solving and decision-making skills with a focus on efficient project execution.
  • Ability to work in a global environment, collaborating with diverse teams and stakeholders.

COMPENSATION & BENEFITS

  • Competitive salary/bonus program.
  • Equity grants that have become highly valuable for Medpace associates.
  • Comprehensive benefits package, including health, dental, and vision coverage.
  • Flexible work environment and remote options for the right candidates.
  • Paid time off (PTO), starting at 20+ days.
  • Employee wellness initiatives, including fitness programs and health resources.
  • Company-sponsored appreciation events and employee recognition programs.
  • Structured career paths with ample opportunities for professional growth.
  • Discounts on local sports events, fitness gyms, and attractions.

AWARDS & RECOGNITION

  • Forbes: Recognized as one of America's Most Successful Midsize Companies (2021, 2022, 2023, and 2024).
  • CRO Leadership Awards from Life Science Leader magazine for excellence in expertise, quality, capabilities, reliability, and compatibility.

WHY MEDPACE?

Medpace is a purpose-driven company, committed to improving patient lives through the development of cutting-edge therapeutics. Join our team to make an impact in the clinical research field and contribute to the success of global health solutions.


HOW TO APPLY

Apply now to become part of Medpace's Clinical Trial Management team and contribute to leading and executing impactful clinical trials.