Clinical Safety Manager

3+ years

Preferred by Comapny

Cincinnati

10 Nov. 25, 2024

Job Description

Job Type: Full Time 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 Opportunity: Clinical Safety Manager

Location: Cincinnati, Ohio
Department: Clinical Safety
Job Requisition ID: 10119

About Medpace

Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. With over 5,000 employees in 40+ countries, Medpace's mission is to accelerate the development of safe and effective medical therapeutics globally. We specialize in therapeutic areas such as oncology, cardiology, metabolic diseases, endocrinology, CNS, and anti-viral treatments.

Role Overview

Medpace is seeking an experienced Clinical Safety Manager to join our Clinical Safety Department in Cincinnati, Ohio. This full-time position will play a key role in the pharmacovigilance process, overseeing clinical safety case management, aggregate reporting, and developing safety management plans. The ideal candidate will bring expertise in clinical research or pharmacovigilance, combined with a desire to grow within Medpace's clinical operations.

Key Responsibilities

Team Leadership & Development:
- Line manage and mentor a team of clinical safety professionals to enhance their skills and career growth.
- Provide guidance and development support for direct reports in managing clinical safety case processing.
Client & Stakeholder Management:
- Build and maintain strong relationships with clients and internal stakeholders by offering expert safety knowledge and insights.
- Address client needs and ensure that safety processes meet high-quality standards.
Clinical Safety Oversight:
- Oversee the clinical safety case management process and aggregate reporting responsibilities to ensure compliance with timelines and quality standards.
- Review and create safety management plans tailored to specific clients and their project needs.
Safety Review:
- Conduct safety reviews of clinical study documents, such as protocols, study reports, and marketing application components to ensure accuracy and compliance with regulatory standards.

Qualifications

Education:
- BSN (Bachelor of Science in Nursing) or equivalent healthcare degree.
- A Bachelor’s degree in a related field is required.
Experience:
- A minimum of 4 years of experience in clinical research or pharmacovigilance.
- At least 1 year of clinical nursing experience.
- Prior project management experience is preferred.
Skills & Attributes:
- Strong leadership and team management abilities.
- Excellent communication skills, both verbal and written.
- High level of attention to detail and organizational skills.

Why Medpace?

Cincinnati Perks & Benefits

Flexible work environment
Competitive compensation and benefits packages.
Generous PTO, starting at 20+ days per year.
Employee appreciation events and health & wellness initiatives.
Community involvement with local nonprofit organizations.
Discounts on local sports, fitness, and attractions.
Modern, eco-friendly campus with on-site fitness facilities.
Discounted tuition for UC online programs.

Recognition & Awards

Top Workplace in 2024 by The Cincinnati Enquirer.
Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
Continually awarded CRO Leadership Awards from Life Science Leader Magazine for expertise, quality, reliability, and capabilities.

How to Apply

To apply for this opportunity, visit the Medpace career page and submit your application under Job Requisition ID 10119.

Join Medpace and contribute to the global development of safe, effective medical therapeutics!

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Clinical Safety Manager

Job Description

Job Opportunity: Clinical Safety Manager

About Medpace

Role Overview

Key Responsibilities

Qualifications

Why Medpace?

Cincinnati Perks & Benefits

Recognition & Awards

How to Apply

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