Covance by Labcorp is a global, world-leading Life Sciences Contract Research Organisation that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry. We strive to make a difference to people's everyday lives by bringing essential medicines to the market.

The CDx Global Study Manager position requires the ability to work in a global virtual team on the tasks relative to the development and management of Companion Diagnostic trials.

This position will serve as a liaison on a global basis between internal Covance Departments and Diagnostic and Pharmaceutical companies regarding Companion Diagnostics study to ensure successful management and delivery of testing results.

The CDx Global Study Manager must show flexibility when appropriate and possesses capability to make decisions, must be able to act as consultant or technical expert relative to allocated portfolio of studies and to demonstrate integrity, dedication and ability to deliver outstanding customer service.

Duties and Responsibilities:

• Participate in protocol review and study feasibility. Act as a consultant in providing recommendations and advice to all applicable parties
• Ability to create and motivate a team around project deliverables
• Provide day-to-day project management oversight; effectively managing, planning and coordinating all project related activities
• Demonstrate through appropriate self organization the ability to manage conflicting priorities and to make difficult decisions
• Able to act efficiently in an environment with dynamic timelines and priorities
• Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients
• Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget
• Participate in Covance CLS development through continuous process improvement, quality and productivity

Regulatory/ Study Documentation

• Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.
• Report Adverse Events as needed.
• Report protocol deviations as needed.
• Acts as an ambassador on behalf of the client within Covance CLS and across Covance business units; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
• Demonstrate a sound working knowledge of internal function and units and Covance business acumen.
• With project team members , develop solutions, resolve issues and approve internal database loading/design plan.
• Serve as an accountable resource upon solicitation by team members.
• Upon consultation and approval with applicable laboratory department management, customize workflow for projects as needed.
• Communicate with Data Managers to assist with resolving data transmission issues; perform data revisions as needed.
• Serve as facilitator and organizer of internal project meetings and technical discussions.
• Coordinate with IT, Lab Compliance, Lab Technology, and/or Quality Assurance on new project start-ups, new instrumentation start-ups, or instrumentation middleware as needed.
• Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
• Host and participate directly in audits or monitoring visits related to Companion Diagnostic studies.
• Act as primary point of contact and liaison for Diagnostic Clients; liaise with CLS Project Management with external Pharmaceutical Clients.

Education/Qualifications:

• Requires BS degree in Biology, Chemistry or other Life Science; or Medical Technology degree.
• Preferably professional certification (ASCP, PMP or other) in area(s) of expertise.

Experience:

• Preferably 5 years of clinical laboratory experience. Experience with multidisciplinary lab background is a plus
• Solid scientific background
• 2- 5 years' experience in managing projects in pharma industry or in a CRO
• Demonstrated leadership skills
• Proven ability to negotiate and collaborate to deliver effectively
• Great customer service skills
• Ability to make difficult decisions and act efficiently in an environment with dynamic timelines
• Dedicated to a culture of quality and continuous improvement
• Strong communication skills
• Fluent in English