Sr. Clinical Trial Manager

About the role

As a Senior Clinical Trial Manager at Bamboohr, you will play a role in overseeing the planning, execution, and management of clinical trials. Your expertise will ensure that trials are conducted efficiently and in compliance with regulatory standards. You will collaborate with cross-functional teams to drive projects forward, ensuring that timelines and budgets are adhered to while maintaining the highest quality of data integrity. This position is ideal for someone with a strong background in clinical research and a passion for advancing innovative therapies.

Key facts

What you'll do

• Lead the strategic planning and execution of clinical trials from initiation through to completion, ensuring alignment with company goals and regulatory requirements.
• Develop and manage study timelines, budgets, and resources, ensuring that all milestones are met on schedule.
• Collaborate with clinical research associates, data managers, and other stakeholders to ensure the execution of clinical protocols.
• Oversee site selection, initiation, monitoring, and closeout activities, ensuring compliance with Good Clinical Practice (GCP) and other applicable regulations.
• Act as the primary point of contact for external vendors and clinical sites, facilitating effective communication and collaboration throughout the trial process.
• Prepare and review study-related documents, including protocols, informed consent forms, and regulatory submissions, to ensure accuracy and compliance.
• Conduct risk assessments and implement mitigation strategies to address potential challenges in trial execution.
• Analyze and interpret clinical data, providing insights and recommendations to the project team and senior management.
• Mentor and train junior staff members, fostering a culture of continuous learning and professional development within the clinical operations team.
• Participate in the development of clinical trial budgets and financial forecasts, ensuring that resource allocation aligns with project needs.
• Contribute to the preparation of clinical study reports and presentations for internal and external stakeholders, highlighting key findings and implications.
• Stay current with industry trends and regulatory changes, ensuring that clinical trial practices remain compliant and innovative.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in clinical trial management, with a proven track record of successful trial execution.
• Strong understanding of GCP, FDA regulations, and other relevant guidelines governing clinical research.
• Excellent project management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Exceptional communication and interpersonal skills, with the ability to build relationships with diverse stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Strong analytical skills, with the ability to interpret complex data and make informed decisions.
• Detail-oriented mindset with a commitment to maintaining high standards of quality and compliance.
• Ability to work independently and as part of a team in a fast-paced environment.

Nice to have

• Experience in oncology or rare disease clinical trials is a plus.
• Familiarity with international clinical trial regulations and practices.
• Certification from a recognized clinical research organization (e.g., ACRP, SOCRA) is advantageous.
• Previous experience in a biotech or pharmaceutical company is preferred.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software.
• Familiarity with statistical analysis software and data visualization tools.
• Strong organizational skills and the ability to manage time effectively.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites.
• The company offers a comprehensive benefits package, including health insurance, retirement plans, and professional development opportunities.
• Candidates should be prepared to provide references and undergo background checks as part of the hiring process.

Join Bamboohr and contribute to the advancement of therapies that can transform patient lives. If you are a dedicated and experienced clinical trial manager looking for a challenging and rewarding opportunity, we encourage you to apply today!

About the company

Medicine is our platform. Accessibility is our cure.