Clinical Project Manager

1 month ago

West Lafayette, United States Cook Medical Full time

Overview

The Clinical Project Manager at Cook Research Incorporated is responsible for the study-level management (execution and closeout) of clinical studies, including clinical study planning, performance analysis, and oversight, while ensuring cross-functional teams are appropriately informed and coordinated to execute the clinical study in order to meet company objectives.

Responsibilities

• Develop and maintain a working knowledge of local and global regulatory requirements and standards (., FDA CFR, ISO 14155, GCP, EU MDR) that impact clinical studies

• Develop and maintain a working knowledge of study specific and general disease pathology/anatomy

• Lead efforts to document and train the internal clinical study team, vendors, and site study team

• Lead and manage internal and vendor activities in support of assigned studies (., site initiation, site visits, auditing, and patient recruitment)

• Develop and coordinate clinical study-related documents, plans, and training materials (.,Study Protocol, Study/Site-specific informed consents, monitoring plan, risk management plan) 

• Provide vigilence over clinical study and track study progress; work with the appropriate clinical study team members and/or management to ensure study activities are being conducted in a timely manner to achieve study objectives and milestones; and provide oversight that the study observes the applicable regulations and standards 

• Maintain effective communication with cross functional teams and stakeholders

• Ensure that appropriate resources are available to achieve study objectives and milestones

• Assist in preparation and submission of regulatory applications for the clinical study, where appropriate 

• Lead efforts, drive the content, and collaborate with the appropriate personnel for external meetings (., Research Coordinator, Investigator, Study Investigator meetings)

• Lead efforts and plans for clinical study meetings and preparation of study materials for distribution to clinical sites

• Ensure proper and timely escalation of critical issues to Clinical Operations management

• Ensure the clinical study is registered and maintained on a public database, when applicable

• Participate in site selection and principle investigator changes during the clinical study

• Ensure clinical study data within clinical systems are accurate and up to date

• Participate in clinical function process improvement strategies

Qualifications

• Bachelor’s degree (scientific, health, or business related field preferred), plus significant relevant experience is required

• Master’s degree with demonstrated research or project management background is preferred

• Previous experience in the conduct of medical device/drug clinical studies (including a knowledge of applicable regulations and standards) is preferred

• Ability to exercise sound judgment and critical thinking in independent decision making

• Outstanding work ethic and strong personal discipline

• Ability to interact with internal and external stakeholders (., study team, physicians, scientists, and business division representatives) in a professional and personable manner

• Capability to handle multiple projects and responsibilities

• Proficient in the following skills sets: time management, leadership, written and verbal communication, problem-solving (., root cause analysis, lean management)

• Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues

• Sufficiently assertive to deal with confrontational situations

• Willingness and ability 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 (., H-1B or TN status) for this employment position

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