Clinical Trial Manager, Biospecimen DC/MP

About the role

Bamboohr is seeking a dedicated Clinical Trial Manager specializing in Biospecimen Data Collection and Management Processes (DC/MP) to join our dynamic team in South San Francisco, California. This role is pivotal in overseeing clinical trials, ensuring that biospecimen data is collected, managed, and analyzed efficiently. The ideal candidate will have a strong background in clinical trial management and a keen understanding of biospecimen handling protocols. You will play a critical role in advancing our innovative therapies, contributing to the overall success of our clinical programs.

Key facts

What you'll do

• Lead the planning, execution, and management of clinical trials focused on biospecimen collection and data management, ensuring compliance with regulatory requirements and company standards.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and laboratory personnel, to develop and implement biospecimen protocols and workflows.
• Monitor trial progress, identifying potential issues and implementing corrective actions to ensure timelines and objectives are met.
• Develop and maintain trial-related documentation, including study protocols, informed consent forms, and case report forms, ensuring accuracy and compliance with Good Clinical Practice (GCP).
• Oversee the training of site personnel and study coordinators on biospecimen collection procedures and data management systems.
• Manage relationships with external vendors and laboratories involved in biospecimen processing and analysis, ensuring quality and timely deliverables.
• Conduct regular site visits and audits to assess compliance with study protocols and regulatory requirements, providing guidance and support as needed.
• Analyze and interpret data related to biospecimen collection and management, preparing reports and presentations for stakeholders and regulatory submissions.
• Ensure that all biospecimen data is accurately entered into databases and maintained according to data integrity standards.
• Participate in the development of budgets and timelines for clinical trials, monitoring expenditures and resource allocation throughout the study lifecycle.
• Stay current with industry trends, regulatory changes, and best practices in clinical trial management and biospecimen handling.
• Contribute to the continuous improvement of clinical trial processes and systems, identifying opportunities for efficiency and innovation.

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 focus on biospecimen collection and data management.
• Strong knowledge of regulatory requirements, including GCP, FDA regulations, and ICH guidelines.
• Proven track record of managing multiple clinical trials simultaneously, with excellent organizational and project management skills.
• Exceptional communication skills, both written and verbal, with the ability to effectively collaborate with diverse teams and stakeholders.
• Proficiency in clinical trial management systems and electronic data capture tools.
• Strong analytical skills, with the ability to interpret complex data and provide actionable insights.
• Detail-oriented mindset, with a commitment to maintaining high standards of quality and compliance.

Nice to have

• Experience in oncology or rare disease clinical trials.
• Familiarity with biospecimen biobanking and related regulatory considerations.
• Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
• Experience with data management software and statistical analysis tools.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software.
• Familiarity with electronic lab notebooks (ELN) and laboratory information management systems (LIMS).
• Knowledge of data visualization tools and techniques for presenting biospecimen data.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites and partner organizations.
• The salary for this role is competitive and will be determined based on the candidate's experience and qualifications.
• Bamboohr is committed to fostering an inclusive work environment and encourages applications from diverse backgrounds.

META

Company: Bamboohr

Title: Clinical Trial Manager, Biospecimen DC/MP

Listed

location: South San Francisco, California

Job type: Full-Time Employee (FTE)

Apply URL: https://structuretx.bamboohr.com/careers/387