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

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