Biomarker Program Manager

Position Title: Biomarker Program Manager

Length of Contract: 2 years (Potential Extension)

Location: North Chicago, IL 60064, USA/Waltham, MA 02451/South San Francisco, CA 94080- Hybrid Onsite (Can be any of those 3 locations) – no remote candidates

Purpose:

Within Precision Medicine (PMed), the Biomarker Program Management (BPM) team connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. We are seeking an experienced and highly motivated individual who will employ operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decision-making to achieve these objectives, including scientific expertise, strategic thinking, a patient-oriented mindset, team building and cross-functional collaboration.

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 client’s 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 client’s 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. Assist 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.

What are the top 3-5 skills, experience or education required for this position:

• 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.

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