Description

Title: Clinical Project Leader

Reporting Location: ROCKVILLE, MD

Primary Objectives: The Clinical Project Leader (CPL) serves as the primary point of contact for Champions vast portfolio of client sponsors regarding Champions aspects of sponsors clinical trial execution, regulatory requirements, data transfer, and general project management. The CPL is client facing and requires strong customer focus and an understanding of the needs and timelines of the client. The CPL provides expertise to clients on validation and regulatory requirements for endpoint use of testing and monitors Champions adherence to protocols and SOPs. Essential job duties include client communication around study set up, initiation and conduct in collaboration with the business development team, interaction with the various teams to coordinate clinical trial patient sample receipt, study execution, and preparing study protocols/updates/analyses/reports in compliance with regulatory requirements. Partners with the Business Development team to enhance client relationships and facilitate continued business for Champions Oncology. The CPL will be proactive with regards to client needs for ongoing and future studies, provide excellent customer service, and mitigate miscommunications that occur in the preparation, execution, and delivery of analytical biomarker projects.

DUTIES, RESPONSIBILITIES AND PRODUCTIVITY EXPECTATIONS:

• Enters all samples are tracked and monitored by using the LIMS.
• Writes, prepares, and reviews any additional clinical trial documents as needed for conduct of biomarker analyses at Champions with the support and oversight of the Head of Clinical Operations and/or clinical lab management.
• Assists in client audits and client questionnaires as needed.
• Organizes kickoff and protocol review meetings with clients and internal staff.
• Participates as project manager and supports the technical lead(s) in client meetings related to potential and current opportunities.
• Monitors ongoing study data to ensure any deviations are identified and communicated to the client in a timely manner.
• Securely delivers study data at regular intervals and at completion of client studies.
• Provide weekly updates, data analysis, and final reports to clients (where applicable).
• Recognizes revenue for development, validation, and sample analysis.
• Maintains sample lists for clinical trials and preclinical biomarker studies for client review.
• Organizes shipment of samples to the client as needed.
• Interfaces with Business Development, Operations, and other Champions personnel to successfully coordinate projects from start to finish.
• Identifies and provides resolution to problems involving ongoing studies.
• Deliver customer value in a timely manner, and ensure protocols are accurate.
• Writes, revises, and reviews SOPs as needed.
• Identifies and provides resolution to problems involving ongoing studies, as appropriate.
• Participates and provides feedback in team meetings.
• Works independently.
• Other duties may be assigned verbally at any time.

Qualifications

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of project management for clinical trials and oncology research.
• Regulatory expertise, specifically GCLP and GLP, to support clinical trials and preclinical regulatory studies.
• Customer service skills, timely decision making, good interpersonal skills and an ability to be persistent while maintaining tact.
• Must have the ability to balance several priorities simultaneously with high attention to detail.
• Ability for frequent adaptation, self-organization, accountability.
• Effective oral and written communication skills are required.
• Knowledge of LIMS, Microsoft Word, PowerPoint, Excel, and Statistical Software such as GraphPad Prism.

EDUCATION AND EXPERIENCE:

• M.S degree in chemical/biological science or project management preferred. B.S. degree acceptable with appropriate experience.
• 2 years of experience in the field of study management, GCLP/GLP regulatory or a similar position.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Must be able to sit and use hands to finger, handle and feel. 
• Must be able to lift and move packages weighing up to 50 pounds. 
• Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility. 
• Some activities require repetitive motion and reaching, pulling, or pushing. 

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned. We celebrate diversity and are committed to creating an inclusive environment for all employees.