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Clinical Project Manager

1-3 years
$98,000.00 – $196,000.00
10 Feb. 5, 2025
Job Description
Job Type: Full Time Education: B.E./B.tech/BCS/B.Sc 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:** Clinical Project Manager  
**Location:** United States - California - Alameda  
**Category:** Medical and Clinical Affairs  

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### **About Abbott**  
Abbott is a global healthcare leader helping people live fully at all stages of life. With life-changing technologies spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott serves people in over 160 countries. At Abbott, employees have access to career development, health and wellness benefits, a retirement savings plan, and educational opportunities.

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### **Opportunity Overview**  
The **Clinical Project Manager** is responsible for managing clinical projects, including New Technology Assessments (NTA), to ensure successful execution within Abbott's Medical Devices division. This role involves working with cross-functional teams, including clinical research associates, data management, biostatistics, and other stakeholders to meet business objectives and timelines.

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### **What You’ll Work On**  
- **Project Management**: Define objectives, strategy, scope, and schedule for NTAs and clinical projects. Develop detailed project plans in consultation with stakeholders.  
- **Team Training**: Ensure the clinical project team is well-trained on project requirements and processes.  
- **Audit Readiness**: Ensure the clinical project is audit-ready at all times, with proper documentation and system validation.  
- **Clinical Visits**: Conduct clinical visits as needed to support NTA and clinical project execution.  
- **Safety Oversight**: Monitor safety concerns and adverse events during clinical trials and work with the team to address them.  
- **Project Reporting**: Oversee the accuracy of project reports, including budget tracking and trending. Provide clinical input to study summaries, publications, and submissions.  
- **Post-Project Planning**: Provide clinical input for post-project activities and market launch.  
- **Regulatory Compliance**: Ensure compliance with GCP, FDA, ISO standards, and other regulatory guidelines.  

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### **Required Qualifications**  
- **Education**: Bachelor’s degree in Engineering, Biological Sciences, or a related field (Master’s or Doctorate preferred).  
- **Experience**:  
  - Minimum of 3 years of experience supporting clinical research or a similar field, plus 1-3 years managing projects and working with clinical professionals in cross-functional teams.  
- **Skills**:  
  - High attention to detail and accuracy.  
  - Advanced communication and problem-solving skills.  
  - Proficient knowledge of medical terminology and clinical trial guidelines (e.g., GCP, FDA, ISO).  
  - Strong computer skills.  

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### **Preferred Qualifications**  
- Expertise in clinical and outcomes research study design.  
- Demonstrated ability to work effectively in cross-functional teams.  
- Willingness to travel (<25%).  

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### **Compensation**  
- **Base Pay Range**: $98,000.00 – $196,000.00, with potential variation based on location.  

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