Biomarker Operations Project Manager
1 week ago
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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