Senior Clinical Trial Manager

Bayside Solutions; San Francisco (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

Join a forward-thinking company as a Senior Clinical Trial Manager, where you'll oversee the operations of clinical studies, ensuring they meet project goals and comply with regulatory standards. This role involves leading cross-functional teams, managing vendor relationships, and ensuring quality deliverables. With a focus on operational excellence and compliance with GCP/ICH guidelines, you'll play a crucial role in the success of clinical trials. If you have a passion for research and a proven track record in trial management, this opportunity offers a dynamic environment to further your career.

Qualifications

• 5+ years in a pharmaceutical setting with 3+ years of trial management experience.
• Bachelor's degree required; RN/PA with professional clinical experience preferred.

Responsibilities

• Manage day-to-day operations of clinical studies ensuring compliance with GCP/ICH guidelines.
• Lead internal cross-functional study execution team to identify risks and mitigation strategies.

Skills

Clinical Trials

Trial Management

GCP

SOP

Microsoft Office

Interpersonal Skills

Organizational Skills

Education

Bachelor's Degree

Master's Degree in Health-Related Science

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

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Job Summary:

As a Senior Clinical Trial Manager, you will manage the day-to-day operations of clinical studies to ensure completion per established project goals and objectives in compliance with applicable GCP/ICH guidelines and regulatory requirements. You will work closely with a cross-functional team, ensuring that clinical trials are conducted on schedule and complying with SOPs, ICH/GCP/regulatory guidelines, company goals, and budget.

Duties and Responsibilities:

• Lead internal cross-functional study execution team for assigned studies to identify risks and mitigation strategies.
• Lead the preparation of vendor requirements, project scope, and selection of study vendors.
• Manage and assist clinical research organizations to ensure timely and quality deliverables.
• Manage and support 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 the development of study plans, system set-up, and UAT; participate in the 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, 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.
• Ensure all work adheres to ICH Good Clinical Practice (GCP) guidelines and complies with company SOPs.

Requirements and Qualifications:

• Bachelor's degree required; RN/PA with professional clinical experience; 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.
• Able to efficiently perform multiple tasks and manage changing priorities
• Able to identify and solve logistical problems
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Able to build strong relationships with co-workers of various backgrounds and expertise
• Able to function at a high level in a team setting, whether leading the group or acting as an individual contributor

Desired Skills and Experience

Clinical trials, CTM, TMF, GCP, SOP, ICH, Microsoft Office

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Science

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