Clinical Project Manager - Biotech

Responsibilities and Job Duties:

• Project Management - Responsible for overall execution of clinical trials within designated study budgets, timelines and quality standards.
• Clinical Trial Planning - Provides overall operational and strategic input prior to commencement of clinical trials. Directs Clinical Operations team members on daily tasks and activities.
• Monitoring Activities - Oversee and directs other team members on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations.
• Site Management - Develops communication pathways and study specific processes to allow team members to communicate with clinical trial sites regarding all logistics
• Vendor Oversight - Key decision maker in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of third party personnel.
• Internal/External Meetings - Facilitates Clinical Study Team meetings that comprise of cross functional representation.
• Data Listing Review - Oversees in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.
• The Master File - Ensures that the study regulatory files are collected and inventoried and filed as per requirements.
• Ancillary Supplies - Ensures study materials and supplies are appropriately managed in regards to ordering, tracking and within budgetary considerations.
• Study Management Tools - Ensures that study teams and clinical sites have the appropriate study management tools to execute the study.
• Clinical Operations Responsibilities - Act as a key contributor to the Clinical Operations department.

Qualifications, Education & Credentials

• Bachelor's degree in a relevant scientific field
• Minimum of seven years of relevant clinical trial experience in the pharmaceutical or biotech industry with at least two of those years managing clinical trial activities.
• Thorough and integrated knowledge of the clinical trial process
• Ability to influence without authority
• Experience in oncology
• Experience in global trials
• Ability to travel to meetings, sites and vendors approximately 10-20%