Senior Clinical Trial Manager

Senior Clinical Trial Manager

W2 Contract

Pay Rate: $80 - $90 per hour

Location: South San Francisco, CA - Remote Role

Job Summary:

The Senior Clinical Trial Manager (Sr CTM) contractor is responsible for managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. The Senior CTM will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with the SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Duties and Responsibilities:

• Lead internal cross-functional study execution team for assigned studies to identify risks and mitigation strategies.
• Lead preparation of vendor requirements and project scope, and selection of study vendors.
• Manage clinical research organizations to ensure timely and quality deliverables.
• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Lead feasibility assessment and selection of countries and sites for study conduct.
• Lead development of study plans and system set-up and UAT; participate in preparation and ensure operational excellence of protocol, CRF, CSR, and other key study deliverables.
• Implement appropriate systems, standards, and processes to ensure quality at the level of investigative sites, vendors, and data; maintain clinical study files per ICH guidance.
• Oversee the quality of the clinical trial master files.
• Oversee the clinical aspects of timely data cleaning, data analysis, and the availability of top-line results; participate in data reviews and review of statistical analysis plans.
• Author, audit, and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
• Ensure set-up and implementation of effective investigator and site monitor training;
• Coordinate operational and therapeutic area training for internal and external study team members.
• Create and conduct study-specific training at investigator meetings.
• Review study invoices and participate in accrual reviews to track the financial status of the study against the budget.
• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Requirements and Qualifications:

• Bachelor's degree required. RN/PA with professional clinical experience, and/or Master's degree or higher in health-related science or equivalent preferred.
• 5+ years in a pharmaceutical setting (sponsor side experience a plus) with 3+ years of trial management experience required.
• Excellent organizational skills and attention to detail.
• Effective communication and interpersonal skills.
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Ability to identify and solve logistical problems.
• Demonstrate proficiency in Microsoft Word, PowerPoint, and Excel.
• Ability to build strong relationships with co-workers of various backgrounds and expertise.
• Ability to function at a high level in a team setting, whether leading the group or acting as an individual contributor.
• Values-based leadership is consistent with our core values.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.