Biomarker Operations Project Manager

We are looking for an experienced Biomarker Operations Project Manager to join our North America team!

This is a remote position and will be project management and computer-based. In this role, you will support the operational set-up and management of biomarker specimens collected in global clinical trials.

Description of Role & Responsibilities:

• Partner with cross-functional teams to ensure timely achievement of clinical and project related objectives
• Responsible for the implementation of biomarker strategies, in accordance with all quality requirements and ethical & regulatory standards
• Ensure biomarker-related information is accurately captured in areas including trial protocols, specimen logistics and workflows, systems, central lab and clinical site manuals, etc.
• Serve as a subject matter expert for activities associated with biomarker specimens, including interactions with vendors (including labs and biorepositories) during protocol planning and trial execution
• Accurately track biomarker-related activities and effectively communicate with project teams, including timelines, status, risks, and any known issues
• Maintain effective communication and working relationships teams
• Host planning meetings as needed for awareness and alignment

Skills and Experience:

• Basic knowledge of clinical trial set-up and execution is required
• Scientific, medical and/or safety writing and reporting is required (experience in at least one of these areas)
• Experience in working with third party vendors preferred
• Drug discovery and/or development experience is preferred
• Understanding of basic clinical lab techniques is preferred
• Knowledge of GCP, ICH guidelines, and regulatory requirements is preferred
• Ability to collaborate effectively with a team
• Must be self-motivated, and independent with self-awareness to know when to ask questions
• Ability to manage complex projects under accelerated timelines. Formal project management experience is preferred.
• Can independently prioritize work based on project needs and requirements
• Well-organized and methodical approach to problem solving
• Ability to understand needs of stakeholders
• Strong issue identification and resolution skills
• Able to learn quickly and be proficient in applicable tools and databases used to support the activities
• Experience with MS Office Suite
• Excellent communication skills, both written and oral

Educational Requirements: BA/BS with a science background required

Job Industries

• Other