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Job (this posting is now closed/inactive)


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General Information

(3616827)

Job title: Clinical Trial Manager (Sr. or Principal)
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Job location: Morrisville, NC  27560 United States
Requisition code: 17070
Date posted: 05/16/2017
Compensation:
Job category:Clinical Research
Employment type:Full time
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Job Description


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About Array:
Array BioPharma is a biopharmaceutical company headquartered in Boulder, CO with locations in Morrisville, NC and Cambridge, MA. Array is focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.

Summary:
This position resides in our Morrisville, NC office and will be responsible for leading the execution of oncology clinical studies to required quality standards, on schedule and on budget. This is an office-based position.

Responsibilities:
• Oversees the delivery of studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines
• Provides Clinical Operations leadership to CROs, other vendors, CRA team, internal study team, and Project Coordinators
• Develops timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines
• Responsible for developing and implementing robust contingency and issue management plans to solve complex issues that impact study or program milestones
• Manages staff and provides technical advice to team members
• Disseminates clinical study communications to all functional groups and leads study and team meetings
• Interacts with clinical research investigators and sites
• Interacts with Senior Management to report on progress of milestones
• Organizes, attends, presents and provides training at investigator meetings
• Assists or leads development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
• Travel required: up to 20%
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Job Requirements


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• BA/BS or higher degree
• Recent oncology experience in the last 3-5 years required
• 5+ years’ experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)
• Solid technical knowledge of oncology therapeutic area required
• Experience in oversight and management of Clinical Research Organizations (CROs), central laboratories, and other vendors required
• International trial management experience desired
• Phase I study management experience desired
• Demonstrated ability to develop operational strategy for clinical studies, including development of timelines, communication plans, risk management/contingency plans and budgets
• Line and matrix management experience preferred
• Expert knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations
• A strong communicator with excellent verbal and written communication skills
• A highly collaborative person who is able to respond to constantly changing circumstances and needs
• Strong leadership skills, with demonstrated project or program management
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