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The Project Leadership Coordinator (PLC) in this contract opening supports the Path Lab PHCS Project Leadership organization to deliver complex Companion Diagnostic projects in collaboration with pharmaceutical partners and internal initiatives to deliver efficiencies at scale. The PLC will assist with coordination, and delivery of, tactical tasks required to deliver complex Companion Diagnostic projects from Project Start through Product Launch and Commercialization.

Responsibilities

• The PLC must apply solid project coordination and leadership skills to help deliver Companion Diagnostic projects on time, within budget and with high customer satisfaction.
• The PLC will assist in coordination and delivery of internal initiatives that drive efficiencies at scale across the PHCS organization.
• May support multiple projects across multiple product development phases.
• Manages tactical coordination of timelines for pharma collaboration projects within the PHCS Business.
• Maintain project plans and coordinates timelines for assigned project and functions
• Manages execution of cross-functional plans and track of progress of activities
• Works with the Clinical Study Manager to ensure regular monitoring of clinical study has occurred.
• Works closely with the Clinical Study Manager to ensure proper management under GDP and GCP.
• Works with the CDMA team to ensure Clinical study reports and clinical study data to Pharma and internal teams.
• Organizes interdepartmental activities ensuring completion of the projects on schedule and within budget constraints; maximizes project resources.
• Implements / pulls in best practices; fosters continuous improvement by ensuring knowledge, experience exchange.
• Organizes and manages project meetings, including setting agendas, leading meeting discussions, ensuring minutes are taken and tracking risks and action items.
• Performs miscellaneous duties and special projects as assigned
• Other duties as assigned by management

Qualifications:

• 2-5 years project and/or clinical trial coordinator/management experience in a FDA regulated, CRO, diagnostic, and/or pharmaceutical industry dealing with regulated documentation and processes.
• 2-5 years’ experience with clinical trial management and bio-sample (clinical testing) management and quality assurance.
• 2-5 years’ experience with projects that require rapid activity/milestone achievement.
• Knowledge of Diagnostic and/or Pharmaceutical industry and relevant diagnostic area.
• Knowledge and understanding of Clinical Trials management and bio-sample (clinical testing) management and process flow
• Understanding of Quality and Regulatory processes.
• Knowledge of IRB/Ethics committee, Regulatory (Pharma/Medical Device) oversight processes.
• Strong negotiation and meeting facilitation skills.
• Strong written and verbal communication skills
• Good leadership and project management skills. Displays effective interpersonal skills and ability to work in a team environment
• Proficiency with word processing, spreadsheet, database and email software (e.g., Google Mail, Google Calendar, Google Sheets and/orMicrosoft Excel
• Working knowledge of MS Project and/or Smartsheets, Microsoft Word, Laboratory Management Information Management Systems).
• Ability to multitask and coordinate own day-to-day activities. Ability to work under time pressure while maintaining high standards of precision and data quality.
• Ability to apply specialized knowledge and skills in the functional areas, particularly interfacing with cross-functional team representatives.
• Ability to identify, align, and execute process improvements to deliver efficiencies at scale.
• Previous experience with standard project management process (PMI) desired.