Principal Clinical Project Manager - Remote

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

Job Description

The Principal Clinical Project Manager (CPM) is responsible for assisting with the execution of high-quality clinical studies and will focus on the oversight and monitoring of investigational data to ensure compliance.

Job Duties

• Leads and drives the project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical trials including but not limited to:
  • Data management activities such as query generation and resolution, and reporting of adverse events and protocol deviations.
  • Development and implementation of site corrective actions as needed to address any compliance issues.
  • Study training for investigators and coordinators, contract research organization (CRO), Data and Safety Monitoring Board (DSMB) and/or Clinical Events Committee (CEC), or core labs
  • Site qualifications, activations and initiation processes, including budget and contract management and review of site activation documentation
• Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
• Owns and manages the clinical trial budget including developing the budget, forecasting, and accruals.
• Ensures the project team maintains a continuous state of audit readiness.
• Prepares study related documents including clinical protocols, informed consent forms, case reports forms, monitoring plans, study manuals, and other study related tools.
• Manages partnership with CRO and other external vendors.
• Leads the proactive identification, assessment, and management of clinical study risks, in collaboration with the project team.
• Informs and presents study progress and known risks to Senior Leadership.
• Provides clinical input to product development activities; may represent Clinical on product development teams.
• Facilitates the planning of, and preparing materials for, investigator and coordinator meetings
• Ensures that appropriate resources (personnel, tools, etc.) are maintained for Quality System compliance and audit readiness
• May coordinate, schedule, and conduct monitoring visits at investigational sites to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source document verification, writing or reviewing monitoring reports and follow up letters, and device accountability 
• Mentors and coaches all levels of the Clinical team. 

Job Qualifications

Required:

• Able to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligence.
• Proficient computer skills (Electronic Data Capture, Microsoft Word, Excel, PowerPoint, MS Project, etc.)
• Strong organizational skills with high attention to detail and degree of accuracy
• Skilled at collaborative and individual problem sol