Essential Skills Needed for Assignment:
• Under the direction of the Global Clinical Operations Lead, serves as the leader and coordinator for the management of clinical trial activities for global Ph II and III clinical trial(s)
• Performs Project Management responsibilities in the management and coordination of the clinical trial activities performed by the CRO and service-specific vendors
• Manage the coordination of activities between vendors
• Manages the CROs and service-specific vendors in their management and completion of clinical trial activities in accordance with ICH, GCP and company SOPs
• Manages and leads the study team’s deliverables in accordance with the study timelines
• Manages and reports study milestones, status updates and alerts study team of potential delays
• Initiates the study team’s development and implementation of risk mitigation strategies
• Provides clinical input into cross-functional activities and key clinical study documents
• Manages the overall quality of the study data
• Position requires approximately 10% domestic travel
Education and Experience:
• Position requires a minimum of a Bachelor’s degree, preferably in a health/medical related field or life sciences
• Must have a minimum of 5 years clinical trial management experience in the pharmaceutical or biotechnology industry, with emphasis in global, oncology clinical trials
• Must possess a strong understanding of clinical drug development, GCP and the regulatory requirements for clinical trials
• Must have a thorough understanding of clinical study design, CRF design, project management and data handling
Technical/Non-Technical Skills:
• Must have strong leadership skills in leading cross-functional study team members
• Must have strong project management skills
• Must be able to manage and coordinate several vendors
• Must have experience managing CROs and service-specific vendors
• Must possess strong organizational, communication and interpersonal skills
• Under the direction of the Global Clinical Operations Lead, serves as the leader and coordinator for the management of clinical trial activities for global Ph II and III clinical trial(s)
• Performs Project Management responsibilities in the management and coordination of the clinical trial activities performed by the CRO and service-specific vendors
• Manage the coordination of activities between vendors
• Manages the CROs and service-specific vendors in their management and completion of clinical trial activities in accordance with ICH, GCP and company SOPs
• Manages and leads the study team’s deliverables in accordance with the study timelines
• Manages and reports study milestones, status updates and alerts study team of potential delays
• Initiates the study team’s development and implementation of risk mitigation strategies
• Provides clinical input into cross-functional activities and key clinical study documents
• Manages the overall quality of the study data
• Position requires approximately 10% domestic travel
Education and Experience:
• Position requires a minimum of a Bachelor’s degree, preferably in a health/medical related field or life sciences
• Must have a minimum of 5 years clinical trial management experience in the pharmaceutical or biotechnology industry, with emphasis in global, oncology clinical trials
• Must possess a strong understanding of clinical drug development, GCP and the regulatory requirements for clinical trials
• Must have a thorough understanding of clinical study design, CRF design, project management and data handling
Technical/Non-Technical Skills:
• Must have strong leadership skills in leading cross-functional study team members
• Must have strong project management skills
• Must be able to manage and coordinate several vendors
• Must have experience managing CROs and service-specific vendors
• Must possess strong organizational, communication and interpersonal skills