Clinical Trial Manager

Category:

Life Science

Employment Type:

Contract To Hire

Reference:

BH-381178

The Clinical Trial Manager is a key member of a small clinical operations team that is implementing a number of early-stage clinical programs evaluating multiple investigational therapeutic drugs for chronic diseases. This is a temp-hire, hybrid role, requiring 3 days a week onsite in South San Francisco
Salary Range: 131K-153K
Hourly Rate: $63-73/hr

Responsibilities:

• Develop and execute high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies.
• Assist with the selection of Service Providers and investigational clinical sites.
• Manage Service Providers including training and oversight
• Draft and coordinate study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Develop and maintain study timelines and study budgets
• Prepare interim/final clinical study reports.
• Contribute to the development of abstracts, presentations, and manuscripts.
• Monitor and track clinical trial progress and upkeep of status update reports.
• Identify program risks and development and implementation of mitigation strategies.
• Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
• Ensure GCP compliance and inspection readiness are maintained throughout study conduct.
• Perform oversight of central laboratories and other ancillary vendors during start-up, conduct, and

• Bachelor's degree and/or RN degree is required.
• A minimum of 5 or more years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.
• In depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guidelines, and other applicable regulations and practices is required.
• Experience of early clinical development, particularly with MASH, antiviral, or anti-infectious disease compounds is preferred.
• Must have excellent teamwork, communication, decision-making and organizational skills plus a thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Excellent communication, organizational, negotiation and interpersonal skills required.
• Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required.