Position Overview

The Analytical Project Manager (APM) is responsible for the overall conduct of the work defined by the analytical plan. APMs will act as the Analytical Plan representative through study initiation, project monitoring and closing. APMs will work cross-functionally with customer facing teams, laboratory operations, and regulatory groups to create and execute best-practice documents and plans for ensuring accurate and timely execution of regulated projects for clinical studies and trials at Adaptive.

Key Responsibilities and Essential Functions

• Ensure the end-to-end receipt, handling, processing and data delivery for all samples meets the contractual and regulatory requirements, including GCLP guidelines
• Write, provide input to, and/or edit documents to ensure that all GCLP trials have a completed and approved analytical plan prior to the start of execution at Adaptive
• Acts as the analytical project manager, to prepare, manage and deliver analytical plans and analytical reports, when appropriate for the study
• Maintain records of study activities commensurate with the level of regulation of each study
• Reviews SOWs and collaborates with senior team members and leadership to determine compliance for novel proposals
• Develop strong relationships with Research Account Managers and Client Data Managers to manage expectations, deadlines, results, and deliverables for a diverse array of regulated projects
• Coordinate with a broad range of MLO personnel to develop required preparedness prior to receipt of new shipments and to properly disposition samples after processing
• Customer engagement including project kick-off and progress meetings and communication of non-standard sample processing issues
• Act as subject matter expert for external/internal audits
• Write/update SOPs to maintain compliance with quality systems
• Cultivates relationships with Clinical Trials Managers to support shared regulated projects
• Enable long term improvements and ongoing team development while accommodating increasing project volume and complexity
• Perform regulatory responsibilities per Good Clinical Practices (GCP)

Position Requirements (Education, Experience, Other)

Required

• Bachelor's degree and 4 years of experience in a laboratory setting (clinical lab preferred); or Master's degree and 2 years of experience in a laboratory setting (clinical lab preferred)
• Understanding of regulatory requirements, (CLIA/CAP, ISO, GxP), related to clinical trial/study management
• Working knowledge of clinical molecular biology techniques and sample handling best practices

Preferred

• At least one year of prior experience in project and/or program management with RUO and clinical pharmaceutical clientele
• Advanced coursework in biology (including molecular biology and molecular genetics)
• At least two years' experience working in an operations role for a high volume, clinical laboratory performing NGS
• Strong analytical and planning skills with keen attention to details and deadlines
• Proven critical thinking skills and the ability to identify and communicate issues while proposing possible resolutions.
• Strong interpersonal and communication skills, both written and spoken
• Ability to read, write, speak and understand English required
• Proficiency with Microsoft Office Suite of applications
• Previous LIMS experience highly desired. Experience with Salesforce a plus.

Working Conditions

Must be willing to occasionally work non-standard hours to meet deadlines

Physical Requirements

Prolonged periods of working at a computer

#LI-Remote

Compensation

Salary Range: $70,000 - $105,000

Other compensation elements include:

• equity grant
• bonus eligible