Senior Principal Scientist managing clinical research activities involving investigational compounds in Immunology. Focusing on late - stage development and comprehensive clinical trial management.
About the role
- Senior Clinical Trial Manager managing Phase 1 clinical research studies and collaborating with cross-functional teams in a global biopharmaceutical environment.
Responsibilities
- Responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities.
- Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage.
- Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.
- Oversees their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees.
- Delivers operational results that have direct impact on immediate or short-term department results.
- Manages a team of individual contributors and/or Supervisors.
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
- Oversees site interactions post activation through site closeout.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
- Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Strong conflict resolution skills
- Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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