BIOMARKER PROGRAM MANAGER III

Responsibilities

• Manage biomarker operations and logistics to support the clinical trial schedule.
• Resolve or escalate biomarker study-related issues with PMed Lead or BPM Subject Matter Expert (SME).
• Responsible for relevant biomarker content in clinical study documents and associated systems (including clinical trial blueprint/protocol, informed consent forms, eCRFs, CSRs, etc).
• Ensure consistency across studies.
• Manage EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining biomarker standard language and study timelines.
• Responsible for generating study related training materials for the study team, study sites and vendors for each trial.
• Manage biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with procedures and applicable regulations.
• Responsible for the accurate forecasting and tracking of study costs associated with sample and results management, bioanalytical assays, logistics and shipping.
• Identify and resolve and/or escalate study-related issues and risks.
• Aid other team members to resolve risks.
• Lead efforts to improve PMed processes.
• Update BPM training materials to keep them current.
• Lead training for new PMed members for some sections of the Process Guides.
• Oversee sample analysis and data transfer tasks, ensuring timely sample shipments to vendors and/or storage sites and that the data are transferred to the correct databases.
• Oversee sample management, storage and/or destruction, per requirements.
• May work with or manage a Sample Operations Manager with responsibility for these tasks.
• Understand and ensure the biomarker strategy is implemented in trial documents and processes.
• Provide leadership and mentoring for team members; responsible for developing the expertise of team members.
• May manage contract or FTE, as needed.
• Set a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels.
• Balance multiple priorities in a fast-paced, team-based environment and set priorities for self per Department needs.
• Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines.
• Ensure appropriate documents are added to the Trial Master File.

Qualifications

• Ph.D. Degree with 2+ years project management, clinical trial experience and biological science background, including biomarkers.
• Master’s Degree with 7+ years project management, clinical trial experience and biological science background, including biomarkers.
• Bachelor’s Degree with 10+ years of project management, clinical trial experience and biological science background, including biomarkers.
• Proven track record of clinical trial and project management experience; proven ability to work well on teams.
• Excellent oral and written communications skills in English.
• Expertise in MS Office applications including Excel, Word and PowerPoint.
• Organization, attention to detail and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills.
• Experience interacting with various levels within the organization, as well as vendors.
• Demonstrated ability to run meetings, work collaboratively in a cross-functional environment and drive for success.
• Experience with and/or willingness to manage and mentor direct report(s).
• Scientific knowledge of the therapeutic area to be supported, a plus.
• Project Management certification preferred.
• Ability to work in a fast-paced, complex environment with minimal supervision.