Requisition ID 2020-8187 Job Location(s) West Lafayette IN United States Position Type Full Time Company Cook Research Inc. Category Clinical
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, ICH GCP, EU MDR) that impact clinical studies
Develop and maintain a working knowledge of study specific and general disease pathology
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 vigilance 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; comply with the global clinical function quality system procedures/instructions; 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 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
Participate in site selection and principal 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 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 skill 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.
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.