Clinical Trial Manager, Clinical Development Services

Regulatory           ·             Boston, MA           ·          Full time

PathAI’s mission is to improve patient outcomes with AI-powered pathology. Our platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine learning. Our team, comprising diverse employees with a wide range of backgrounds and experiences, is passionate about solving challenging problems and making a huge impact.

The Clinical Trial Manager (CTM), Clinical Development Services will oversee cross-functional PathAI teams collaborating to support biopharma client clinical trials. The CTM will be the critical point of contact and the operational voice of the study from PathAI; managing all routine interactions with the biopharma sponsor and responsible for the overall trial management of the PathAI biomarker and diagnostic testing trial deliverables.

What you’ll do:

Clinical Trial Management:

• Responsible for the overall coordination and management of clinical trials from start up through to final deliverables
  • Owns the timelines of a clinical trial project and is accountable for keeping the study on track
  • Directs the technical and operational aspects of assigned clinical trials, ensuring the successful delivery of contracted work
  • Provides input into and/or developing PathAI study related materials, as well as providing input for sponsor developed materials (example the sponsor Clinical Study Protocol, PathAI’s study monitoring plan, Analytical Plan, Data Management Plans, eCRF, pathology strategy, site lab manual, site training materials, site instructions for specimen collections, etc.)
  • Leading and guiding the internal clinical trial team and chairing study team meetings with relevant communication of decisions and actions.
• Preparing study timelines, deliverables and budget. Working with Project Management and key organizational stakeholders to deliver studies within timelines, scope and budget, aligned with the clinical development plan and following all compliance and quality requirements over the course of the trial.
• Works with major functional area leads to identify and evaluate requirements for successful deployment and helps identify key gaps over the course of the trial. Helps track and interpret data on complex issues, makes sound business decisions and ensures appropriate cross-functional solutions are implemented.
• Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate project management and deliverable timing forecasts, reviewing pass-through costs and ensuring timely invoicing with the support of Project Management Finance and Business Development while working in collaboration with other functional area leads.
• Proactively identify trends and provide feedback to internal departments and/or client on performance of both the Investigator and the PathAI BioPharma Laboratory to ensure timely service delivery.  Examples may include:
  • Responsible for liaising with the biopharma sponsor team on activities around oversight metrics, regular updates on trial performance and quality performance with trial specific metrics and plans
  • Overseeing and tracking patient sample testing and proactively identifying ways to prevent analysis and reporting delays
  • Reviewing monitoring reports, protocol deviations and data for studies to ensure reliable quality data are delivered. Raising issues proactively to ID and resolve any issues or concerns
• Collaborate with business development and relevant functions in development of the trial statement of work and contract development with trial specific operational details

Proactive lines of communication:

• Leading and guiding the internal clinical study team and chairing study team meetings with relevant communication of decisions and actions
• Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery

Adherence to PathAI Quality Standards

• Primary responsibility for clinical trial specific inspections/audits for assigned studies, together with the Quality Assurance representative
• Co-writing/maintaining SOPs within the Clinical Operations department
• Adhere to the Code of Federal Regulations (Title 21) and guidelines set up by the International Committee for Harmonization for good clinical practices
• Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable regulations

What you’ll need:

• Clinical trial operational experience in phases I, II and III of drug development and is an operational expert in clinical trial activities from start-up, execution, to closure
• Experience working with biopharma sponsors on clinical trial management with an understanding of pharma R&D and clinical development; particularly in a CRO or biopharma clinical trial biomarker or diagnostic testing setting
• 8+ years experience in clinical trial study support and management; of increasing responsibilities. Preferably global clinical trial management experience of 2+ years.
• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Experience with management of biomarker and companion diagnostic trials is preferred
• Experience managing global clinical trial logistics, kitting and sample management is a plus
• Cross functional project management with emphasis on quality, time, cost management and financial acumen
• Effective communication skills (listening, oral, written) and cross-cultural awareness in working with diverse sponsor teams and geographies
• Sound interpersonal skills as an influencer and team leader to motivate and coordinate teams
• Flexible and adaptable to changing demands from the clinical trial teams and ability to successfully manage multiple stakeholders
• Highly organized and proficient at multi-tasking; with great attention to detail and ability to delegate and prioritize project team activities
• Proficiency in use of project management tools (example Smartsheet)
• Ability to travel to internal and client meetings 10-20 % of the time

Project Management Certification is a plus

Please click here to apply.