Note: The job is a remote job and is open to candidates in USA. Merck is a leading global healthcare company, and they are seeking a Clinical Pathology Scientist to support clinical teams in the use of pathology in clinical trials. The role involves oversight of pathology deliverables, collaboration with internal and external stakeholders, and leading initiatives to enhance pathology strategies and processes.
Responsibilities
• Provide day-to-day oversight of key pathology deliverables on trials
• Interface with internal stakeholders and external collaborators (such as pathology service vendors) to ensure seamless execution and support for the pathology component of clinical trials
• Become an expert in at least one group of disease indications, supporting internal and external teams, applying efficiencies and standards developed while supporting the portfolio
• Execute and manage existing pathology strategies for early and late-stage clinical trial support
• Exercise foresight and judgment in planning, organizing, and guiding complex pathology projects
• Work across departments to advance pathology processes, and as needed, challenge the status quo to foster innovation
• Provide recommendations to enhance technologic pathology strategies and support systems
• Work with quality and compliance teams for quality-related decision making internally, and to support audits of pathology service providers
• Apply understanding of regulatory requirements to support questions related to filings and regulatory strategy related to pathology
• Support industry presence for our company in clinical pathology at national meetings
• Support internal initiatives and collaborations with a focus on process improvement, identifying solutions and recommending a course of action
Skills
• Education Minimum Requirement: Bachelor's degree required
• At least 10 years of experience supporting clinical development in industry
• Minimum 5 years experience in a similar role at a central research laboratory (CRO) lab
• Knowledge of the use of pathology in clinical trials for evaluation of efficacy and safety
• Skill in authoring clinical pathology operations documents for trials using pathology for evaluation of efficacy and safety
• Regulatory experience supporting drug filings
• Accountability
• Clinical Immunology
• Clinical Pathology
• Clinical Trials
• Collaborative Development
• Cytopathology
• Cytotechnology
• Diagnostic Pathology
• Foster Innovation
• Pathology
• Personal Initiative
• Process Improvements
• Quality Control Management
• Regulatory Requirements
• Stakeholder Relationship Management
• Test and Evaluation (T&E)
• Trial Support
• Histotechnologist certification or Anatomic Pathology Assistant certification
• Experience working at, or working closely with, anatomic pathology core laboratories
• Experience collaborating with colleagues in cross-functional groups to improve and implement processes required for complex pathology deliverables
• Auditing
• Audits Compliance
• Biomedical Sciences
• Business Process Improvements
• Cardiology
• Clinical Chemistry
• Clinical Development
• Clinical Medicine
• Clinical Presentations
• Clinical Research
• Clinical Trial Designs
• Decision Making
• FDA Regulations
• Gastroenterology
• Hematology
• Initiative Activity
• Innovation
• Lean Process Improvements
• Long Term Planning
• Medical Imaging
• Nephrology
• Neurology
• Oncology
• Ophthalmology
Benefits
• Medical
• Dental
• Vision healthcare
• Other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
Company Overview
• Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases. It was founded in 1891, and is headquartered in Rahway, New Jersey, USA, with a workforce of 10001+ employees. Its website is http://www.merck.com.