
Clinical Science Program Specialist
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Overview
Job Description
The OpportunityManages multiple clinical testing and lab services projects from initiation through contract completion undersupervision of Program Manager. Acts as primary point of contact to Pharma customers.Performs tactical coordination of timelines for all projects and functions within CDx Pharma Services and:
Develops project plans, establish 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.Oversees 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 byensuring knowledge and experience exchangeGuides and manages cross-functional interactions to complete the assigned projects within the deadline.Interfaces with resources outside of the company (Contract Research Organizations (CROs), siteinvestigators, client counterparts, etc.) and serves as single point of contact with Pharma andclients.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 andclients.
RequirementsAt least 2 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentationExposure to clinical studiesExperience with clinical projects that require rapid activity/milestone achievement.Strong communication, collaboration, and organizational skills are requiredBachelor's degree is required (Life Sciences is preferred)PreferredPrevious 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 diagnosticsDiagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred.
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