Clinical Science Program Specialist

• At least 2+ years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentation.
• Exposure to clinical studies.
• Experience with clinical projects that require rapid activity/milestone achievement.
• Strong communication, collaboration, and organizational skills are required.
• Bachelor's degree is required (Life Sciences is preferred).

Responsibilities:

• Performs tactical coordination of timelines for all projects and functions within CDx Pharma Services.
• Develops project plans, establishes and coordinates timelines for assigned projects and functions.
• Manages execution of cross-functional plans and tracks progress of activities.
• Identifies gaps, potential bottlenecks or delays and challenges assumptions.
• Oversees and guides day to day activities of sample process flow and accurate reporting of results.
• Implements best practices within the clinical sciences team; fosters continuous improvement by ensuring knowledge and experience exchange.
• Guides and manages cross-functional interactions to complete the assigned projects within the deadline.
• Interfaces with resources outside of the organization (Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serves as single point of contact with Pharma and clients.
• Manages meeting activities such as setting agendas, organizing meeting time and editing meeting minutes.
• Tracks, maintains and communicates project reports and clinical study data to Pharma and clients.

Nice to Have:

• Previous experience with standard project management process (PMI) desired.
• Experience in clinical trial management and knowledge of bio-sample (clinical testing) management and process flow preferred.
• Preferred experience in clinical studies or companion diagnostics.
• Diagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred.