Associate Clinical Project Manager

Cook Medical - West Lafayette, IN

Full-time

West Lafayette, IN

Merchant Wholesalers, Durable Goods

About the position

The Associate Clinical Project Manager (ACPM) position is responsible for supporting the management of daily operational and logistical activities of clinical studies. The role involves assisting the clinical team in reaching milestones, managing investigational device logistics, and ensuring compliance with regulatory standards. The ACPM collaborates closely with study teams to facilitate communication and establish work priorities.

Responsibilities

• Work closely with the clinical study team and provide assistance in ensuring timely study activities and compliance with quality system procedures.
• Assist in preparing clinical studies for audit-readiness by reviewing key documents for compliance with regulatory authority criteria.
• Develop and maintain knowledge of best practices for quality review of documents uploaded to the Clinical Document Management System.
• Provide assistance with query management.
• Maintain a high level of knowledge of local and global regulatory requirements and standards impacting clinical studies.
• Develop a general working knowledge of study-specific and general disease pathology.
• Provide logistical support for study materials and documentation.
• Assist in preparing and coordinating internal meetings and external clinical study meeting logistical needs.
• Attend study team meetings, take notes, and assist with generating meeting minutes.
• Prepare for monitoring visits by reviewing eTMF/CTMF documentation.
• Perform electronic data capture (EDC) administrative tasks as needed.
• Assist the Clinical Project Manager (CPM) with site and study-related documents and reports throughout the study lifecycle.
• Obtain and manage clinical study insurance, if applicable.
• Lead investigational device logistics locally and globally, maintaining documentation for product accountability.
• Facilitate site selection activities and maintain documentation for clinical site/Principal Investigator selection.
• Facilitate review and selection of Principal Investigators and Steering Committee Members.
• Ensure all clinical study documentation is audit-ready.
• Provide assistance and support for other clinical study activities as needed.

Requirements

• Associate's/Bachelor's degree in a scientific, health, or business-related field or equivalent work experience.
• Previous experience in supporting research or medical device/drug clinical studies is preferred.
• Strong work ethic and personal discipline.
• Ability to work independently and prioritize important tasks.
• Desire to work in a collegial team atmosphere with professional communication skills.
• Good computer skills with aptitude to learn new software platforms.
• Experience with Microsoft Office tools (Word, Excel, PowerPoint).
• High level of accuracy and attention to detail.
• Strong organization and time management skills, with the ability to manage multiple projects.
• Excellent critical thinking, written, and verbal communication skills.
• Willingness to attend early morning or late evening teleconferences as needed.
• Ability to travel as required.
• Maintain a positive attitude in challenging situations.