The Early Detection Project Manager is responsible for managing biomarker/companion diagnostic projects (including tracking of timelines, budget, milestones and communication of project status through Microsoft Project Server), and implementation of biomarker strategic objectives in clinical trials including, sample logistics, timeliness, and biomarker administrative needs (budget, presentations and study documents). The PM will need to have experience with biomarker development, companion diagnostics or other types of programs like genomics, genetic prognostic and predictive markers, bioinformatics and/or companion diagnostics. Would prefer oncology background, but other therapeutic experience that involves large data sets would be sufficient.
• Manages and coordinates agenda driven meetings with external collaborators.
• Tracks timelines, budget, milestones, and status of the portfolio of biomarker projects.
• Manages biomarker vendor Purchase Orders, and in partnership with Business Operations, track and reconcile vendor invoices and milestone payments.
• Assistance with biomarker operations activities including sample tracking and management of biomarker data in support of data analysis timelines, risk and quality plans.
• Ensures biomarker operational tracking and project management tools are utilized to meet the needs of the team.
MINIMUM 5 years of experience in Device or CRO environment
Bachelor’s degree in life sciences degree minimum (Masters or PhD preferred)
CPM or PMP Certification is required
Desired Skills, Experience and Competencies:
• Strong knowledge and understanding of clinical research, ICH GCP, GLP, data management, and regulatory and legal issues related to samples.
• Subject matter expertise in Oncology and biomarkers.
Remote: Early Detection Project Manager (232066)