Clinical Project Manager

Posting Date 7 days ago(11/18/2020 12:34 PM)
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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