Project Manager - Clinical Development (FT, 40 hours) at BioReference Labs in Gaithersburg, Maryland

Job Description:

This is an exciting time to join our dynamic organization. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets, including pharmaceuticals, diagnostics, and biologics. OPKO's diagnostics business includes BioReference Laboratories, the nation's third-largest and fastest growing clinical laboratory over the last 35 years, which provides diagnostic testing to physician offices, hospitals, and clinics, among others, and GeneDx, a rapidly growing genetics and genomics laboratory that applies cutting edge technologies to make efficient clinical diagnostic testing and interpretation available for individuals with rare and common genetic conditions. Come join our team and become part of something big, by making our patients and customers the highest priority.

We are seeking an experienced  Project Manager for our clinical development team. In this role, you will be responsible for working with stakeholders and developers to ensure the successful and timely completion of ClinDev projects.

Responsibilities

• Manage ClinDev project development including both internal and external resources


• Collect and document project requirements from Clinical Development teams


• Ensure that project requirements and milestones are met


• Coordinate the testing, validation, and deployment
  
  

• Prepare and manage ClinDev documentation


• Communicate project progress to stakeholders and senior management

Qualifications

• 2+ years professional experience as a project manager


• 3+ years professional experience in a diagnostic or other high-throughput genomics laboratory


• BS or MS in Computer Science, Information Systems, Biochemistry, Molecular Biology, or a related field

• Proficiency using project management software


• Strong written and oral communication skills


• Demonstrated ability to work in a team environment

Additional Preferred Skills

• Experience working in a regulated clinical laboratory environment (CAP/CLIA/FDA)


• Experience with Exemplar, Clarity, or other NGS LIMS/LIS


• Familiarity with best practices for managing software deployment


• PMP certification