Clinical Science Program Specialist

Job Description

Duties and Responsibilities:

• Manages multiple clinical testing and lab services projects from initiation through contract completion under Supervision of Program Manager.
• Acts as primary point of contact to Pharma customers.
• Performs tactical coordination of timelines for all projects and functions within Client Pharma Services and:
• 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 challenge assumptions.
• Overseas and guides day-to-day activities of sample process flow and accurate reporting of results.
• Implements / pulls in best practices within the clinical sciences team; fosters continuous improvement by ensuring knowledge and experience exchange
• Guides and manage cross-functional interactions to complete the assigned projects within the deadline.
• Interfaces with resources outside of the Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serves as single point of contact with Pharma and clients.
• Manage 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 Client clients.

Required Qualifications:

• 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).

Preferred Qualifications:

• 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.