Sr. Clinical Trial Manager

About the role

As a Senior Clinical Trial Manager at Bamboohr, you will play a role in overseeing the planning and execution of clinical trials. Your expertise will ensure that trials are conducted efficiently, adhering to regulatory standards and timelines. You will collaborate closely with cross-functional teams to drive the success of clinical programs, ultimately contributing to the advancement of innovative therapies in the biotech sector.

Key facts

What you'll do

• Lead the design and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and company objectives.
• Oversee all aspects of clinical trial management, including site selection, initiation, monitoring, and closeout activities.
• Collaborate with clinical research associates (CRAs) and other team members to ensure adherence to study timelines and budgets.
• Develop and maintain project timelines, ensuring that all milestones are met and communicated effectively to stakeholders.
• Manage relationships with external vendors, including Contract Research Organizations (CROs), to ensure quality and compliance in trial execution.
• Conduct regular site visits to monitor trial progress, address issues, and provide support to site personnel.
• Prepare and review study-related documentation, including informed consent forms, case report forms, and study manuals.
• Ensure data integrity and compliance with Good Clinical Practice (GCP) and other regulatory guidelines throughout the trial lifecycle.
• Analyze trial data and contribute to the preparation of clinical study reports and publications.
• Facilitate communication between internal teams, external partners, and regulatory agencies to ensure smooth trial operations.
• Participate in budget planning and resource allocation for clinical trials, ensuring optimal use of resources.
• Mentor and train junior staff members, fostering a culture of continuous learning and professional development within the clinical team.

Requirements

• A minimum of 5 years of experience in clinical trial management within the biotechnology or pharmaceutical industry.
• Proven track record of managing multiple clinical trials simultaneously, with a strong understanding of the clinical development process.
• In-depth knowledge of regulatory requirements and guidelines, including GCP, ICH, and FDA regulations.
• Excellent organizational and project management skills, with the ability to prioritize tasks effectively.
• Strong analytical skills, with a keen attention to detail and a commitment to data integrity.
• Exceptional communication and interpersonal skills, capable of building relationships with diverse stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Bachelor's degree in life sciences, nursing, or a related field; advanced degree (e.g., Master's, PhD) is preferred.
• Ability to work independently and as part of a collaborative team in a fast-paced environment.

Nice to have

• Experience in managing trials for biologics or cell and gene therapies is a plus.
• Familiarity with statistical analysis and data interpretation in a clinical context.
• Previous experience in a start-up or rapidly growing company environment.
• Certification from a recognized clinical research organization (e.g., ACRP, SOCRA) is advantageous.

Skills & tools

• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and presentations.
• Experience with project management software and tools to track progress and manage timelines.
• Familiarity with electronic laboratory notebooks (ELN) and data management systems.
• Knowledge of medical terminology and clinical research methodologies.

Practical notes

• This role is based in South San Francisco, California, and may require occasional travel to clinical sites.
• Candidates should be prepared for a fast-paced work environment that demands adaptability and proactive problem-solving.
• Bamboohr is committed to fostering a diverse and inclusive workplace; we encourage applications from individuals of all backgrounds.

META

Company: Bamboohr

Title: Sr. Clinical Trial Manager

Listed

location: South San Francisco, California

Job type: Full-Time Employment (FTE)

Apply URL: https://structuretx.bamboohr.com/careers/446

About the company

Medicine is our platform. Accessibility is our cure.