Job Information
Cook Medical Clinical Project Manager in West Lafayette, Indiana
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 (e.g., 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 (e.g., site initiation, site visits, auditing, and patient recruitment)
• Develop and coordinate clinical study-related documents, plans, and training materials (e.g.,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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., H-1B or TN status) for this employment position
Requisition ID2024-14876
Posting Date1 month ago(7/10/2024 1:41 PM)
Job Location(s) West Lafayette IN United States
Position Type Full Time
Company Cook Research Inc.
Category Clinical