Clinical Project Manager 2 (Finance)
Clinical Project Manager 2
Requisition ID 2025-16090
Posting Date 4 hours ago (2/17/2025 2:40 PM)
Job Location(s) West Lafayette IN United States
Job Locations US-IN-West Lafayette
Position Type Full Time
Company Cook Research Inc.
Category Clinical
Overview
This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, encompassing effective management of stakeholder communication and use of appropriate tools to ensure the successful initiation, planning, execution, monitoring, and closure of studies.
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 assigned;
Provide vigilance over investigational, interventional, or multiregional observational post-market clinical studies 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 affairs quality system procedures/instructions; and provide oversight that the study observes the applicable regulations and standards;
Lead efforts to document and train the internal clinical study team, vendor CRAs and/or CPMs and site study team;
Lead and manage internal and vendor activities in support of assigned studies (e.g., site initiation, site visits, auditing, patient-reported outcomes, and patient recruitment);
Supports and participates in strategic project management initiatives;
Develop and maintain a working knowledge of study specific and disease pathology and anatomy;
Ensure that appropriate resources are available to achieve study objectives and milestones and deliverables;
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);
Maintain effective communication with cross functional teams and stakeholders;
Ensure proper and timely escalation of critical issues to Clinical Operations management;
Provide project trackers for business divisions and manufacturer and lead regular teleconferences to discuss project progress and estimated deliverable dates;
Participate in the review of clinical study reports which includes progress, annual, or final;
Monitor project timelines and scope through the project management software, update study status at least biweekly, and alert management if timelines fall behind schedule;
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., RC, Investigator, SIM);
Lead efforts and plans for clinical study meetings and preparation of study materials for distribution to clinical sites;
Ensure the clinical study is registered and maintained on a public database, if applicable;
Participate in site selection and principle investigator changes during the clinical study; and
Ensure clinical study data within clinical systems (e.g., EDC, DMS) are accurate and up to date.
Qualifications
A minimum of a 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;
At least 3 years of 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 judgments and quick decisions independently;
Outstanding work ethic and strong personal discipline;
Ability to interact with internal and external stakeholders (e.g., study team, physicians, scientists, division representative) in a professional and personable demeanor;
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;
Ability to stay resilient and maintain a professional attitude during challenging situations; and
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.
