Clinical Review Manager

Posting Date 4 weeks ago(3/15/2021 4:47 PM)
Requisition ID
2021-8719
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Research Inc.
Category
Clinical

Overview

Cook Research Incorporated (CRI) is currently accepting applications for a Manager of our Clinical Review Team. This position manages the day-to-day resources and provides leadership and strategic direction for the CRI Clinical Review team in order to achieve Cook global business needs.

Responsibilities

• Coordinate aspects of the Clinical Events Committee (CEC) with Clinical Review team members, including identification and evaluation of adverse events, medical writing, submissions, review and data entry of adjudications, Manuals of Operations (MOPs), work orders, billing, and liaison activities with vendors
• Ensure that the reporting process for adverse events and device performance issues complies with regulatory requirements and company standards
• Oversee centralized and remote monitoring of clinical study data
• 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
• Work closely with Clinical Function management to determine priorities and support the clinical process in order to meet study and Cook objectives
• Coordinate the efforts of the Clinical Review team for medical review of clinical protocols, submissions, case report forms, study-related data, and adverse events
• Support the development and implementation of adverse event reporting systems to meet the evolving needs of the Cook organization
• 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. 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

• BSN degree required; advanced degrees and relevant certifications helpful, but not required
• Experience in the conduct of global clinical studies
• Working knowledge of local and global regulatory requirements and standards that impact clinical studies
• Conscientious, influential person with an outstanding work ethic and strong personal discipline
• Willingness and capability to handle multiple projects and responsibilities

• Sufficiently assertive to deal with confrontational situations
• Excellent organizational, leadership and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work both independently and within a dynamic team environment
• Willing and able to travel as needed

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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