Senior Clinical Trial Manager

1 day ago

Australia Kps Life Full time

Overview Of Role
Responsible for the management and oversight of phase I-IV clinical trials from start up through CSR, including development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring site-level activities, and management of third-party vendors for clinical services. Provides trial management support to the Associate Directors (CST Leads), as assigned.
Responsibilities
Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.
Detailed management and oversight of regional trial activities, as assigned.
Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.
Supports cross-functional clinical study teams to achieve deliverables with high quality, on time, and within budget through information sharing, ongoing study team meetings, and effective risk management planning.
Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff.
Manages global monitoring oversight of site-level activities related to ongoing and planned trials.
Develops and manages detailed project and trial-related plans and documentation and provides regular study status updates to senior management.
Manages vendors\' adherence to contractual obligations, including recognizing changes in scope and coordinating with senior management to ensure timely completion of contractual documents, including change orders.
Provides coaching/mentoring to assigned program staff (CRAs, CTAs) and demonstrates leadership competencies.
Works with Clinical Scientist, Development Lead, and study team to ensure ongoing review of patient profiles and data listings.
Proactively identifies potential resource needs to management.
Participates in development and review of department SOPs and process improvement initiatives.
Position Requirements
Bachelor's degree in the life sciences, healthcare, or related field.
Minimum of 5+ years of clinical trial management experience within pharmaceutical/biotechnology industry, managing the logistics of clinical trial execution.
Experience in rare disease and/or orphan indications is preferred.
Experience managing large and/or complex studies and project teams is preferred.
Demonstrated experience managing CROs and other specialty vendors is essential.
Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
Demonstrated strong leadership skills and ability to work in a matrixed team environment.
Ability to work independently with limited oversight and proactively assist colleagues and/or manager.
Critical thinking, problem-solving, collaboration, and interpretation skills.
Excellent written and oral communication, conflict management, time management, and organizational skills.
Travel
Up to 25% travel, domestic and international required.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Management and Project Management
Industries
Research Services
Biotechnology Research
Pharmaceutical Manufacturing
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