Manager of Clinical Project Management

2 months ago
Requisition ID
2017-3049
Job Location(s)
West Lafayette IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Research Inc.
Category
Clinical

Overview

The Manager of Clinical Project Management position at Cook Research Inc. coordinates appropriate resources required to conduct global clinical studies in order to meet Cook Group objectives.  This person works closely with clinical process management to determine priorities and ensure the timely initiation and conduct of clinical studies.

 

Responsibilities

• Maintain a working knowledge of FDA and other regulatory requirements that may impact global clinical studies including ICH GCP, JGCP, and ISO 14155
• Encourage and foster employee development through mentorship and training
• Provide leadership in accordance with company policies, procedures, applicable laws and regulations that apply to your business activities
• Accountable to CRI executive management and other stakeholders for overall clinical deliverables and timelines
• Work with HR to recruit, interview, select, hire and orient new employees
• Plan and allocate resources to effectively staff and accomplish work to meet functional and company expectations for productivity and quality goals
• Foster an environment where the giving and receiving of feedback is encouraged
• Facilitate the annual employee performance review process coordinated by HR and encourage employee contributions through goal setting, feedback and performance development planning
• Consult HR to document, administer and resolve employee disciplinary action if required
• Maintain ongoing communication with employees through team meetings, one-on-one meetings, email, and other appropriate forms of communication
• Review and approve employee requests through appropriate pathways and according to company policies (e.g. expense reports, purchase orders, PTO approval, education and tuition assistance, and hardware/software workflows)
• Establish trusted relationships with Cook colleagues, management, and external stakeholders by providing respectful, mindful and purposeful communication and maintaining a commitment to exceeding expectations
• Understand, practice and model the principles of honesty and integrity as outlined in the Cook Global Code of Conduct

Qualifications

• Bachelor’s degree with significant relevant experience is required
• Master’s degree in Health, Life Sciences or Biomedical Engineering is preferred
• Working knowledge of FDA and other regulatory requirements that may impact global clinical studies
• Established relationships with other researchers, scientists, and clinicians in the field
• Demonstrated ability to provide consistent leadership in a team setting
• History of successfully managing multiple projects, responsibilities, and deadlines
• Demonstrated ability to manage conflict, communication, and resources across multiple projects

 

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