Clinical Trial Project Manager

About Us:

Founded in 2014, Pangea Laboratory is a California-based diagnostics company specializing in the precise and early detection of emerging diseases. Our commitment to setting new standards in healthcare is evident in our status as a laboratory conducting high-complexity diagnostic testing.

Since 2017, we have held accreditation under the Clinical Laboratory Improvement Amendments (CLIA), demonstrating our compliance with or surpassing federal standards for precision, accuracy, and validity. Further affirming our commitment to quality, we proudly maintain accreditation from the College of American Pathologists (CAP), the gold standard in laboratory testing regulation.

Recognized as a Top Workplace by the Orange County Register in 2022, Pangea Laboratory continues to be a vibrant community where employees thrive, feel connected, and are inspired by their work. If you are passionate about contributing to a new healthcare model that is more responsive to patients' needs and embraces cutting-edge testing technologies, we would love to connect with you!

Job Summary:

Pangea Laboratory seeks a dynamic individual to become an integral part of our Clinical Team. The ideal candidate will have 3-5 years of experience in managing and executing clinical study operations, with emphasis on tumor diagnostics. The ideal candidate is able to accurately translate scientific knowledge into practical applications within the clinical field, and has exceptional organizational skills, the capability to work independently, and a proactive mindset. Previous experience in managing clinical trial operations and ensuring timely and accurate submission of trial results to the FDA is highly desired. This position plays a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our clinical trial programs.

Join us in making a meaningful impact!

Essential Duties and Responsibilities

• Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.
• Serve as primary Sponsor contact for operational project-specific issues and study deliverables.
• Maintain in depth knowledge of protocol, therapeutic area, and indication.
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided.
• Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable.
• Develop operational project plans.
• Manage risk assessment and execution.
• Responsible for management of study vendor.
• Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.
• Serve as the primary point of contact for FDA communications related to our clinical trial programs.
• Prepare and compile all required documentation for FDA submissions.
• Coordinate with internal stakeholders to gather necessary data, reports, and study results for inclusion in submissions.
• Conduct thorough reviews of submission documents to ensure accuracy, completeness, and compliance with FDA requirements.
• Manage timelines and milestones for FDA submissions to ensure timely and successful completion.
• Stay updated on relevant FDA regulations, guidelines, and best practices for clinical trial management and submissions.
• Proactively identify regulatory changes or updates that may impact our clinical trial programs and develop strategies for compliance.
• Conduct regular audits and quality checks to ensure adherence to regulatory requirements and internal standards.
• Foster a proactive and collaborative work environment, promoting open communication and knowledge sharing.

Requirements:

• Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred
• Experience in Phases 1-4; Phases 2-3 preferred
• 5+ years as a project/clinical trial manager within a CRO
• Management of overall project timeline
• Strong leadership skills
• Familiarity with industry-standard clinical data management systems and electronic data capture tools
• Excellent attention to detail, organizational skills, and ability to prioritize multiple tasks in a fast-paced environment
• Strong communication skills, both written and verbal, with the ability to effectively communicate complex information to diverse stakeholders

Compensation:

The estimated base compensation range for this position is $90,000 - $100,000 per year at the time of posting. Actual compensation details will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Equal Employment Opportunity Employer:

Pangea Laboratory welcomes candidates of all backgrounds. These include sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender, gender identity, gender expression, physical & mental disability, medical condition, genetic information, military and veteran status, or any other protected status as defined by federal, state, or local law.

Location:

Fully onsite – Pangea Laboratory HQ – 14762 Bentley Cir. Tustin, CA 92780