Overview
The Associate Clinical Project Manager is responsible for the daily activities of clinical studies and preparing studies for sponsor and site regulatory authority inspections.
Responsibilities
Responsibilities
Work closely with the clinical study team and provide assistance (., running reports, tracking study metrics, communicating timelines, reviewing and uploading documents) in ensuring that study activities are being conducted in a timely manner and comply with quality system procedures, applicable standards, and clinical systems;
Provide assistance for preparing clinical studies for audit-readiness (., reviewing key documents if study is complaint with applicable regulatory authority criteria/checklist);
Develop and maintain a working knowledge of best practice for quality review of documents that are uploaded to the Clinical Document Management System;
Provide assistance with query management;
Maintain a high level working knowledge of local and global regulatory requirements and standards (., FDA CFR, ISO 14155, GCP, EU MDR) and country-specific regulatory requirements that impact clinical studies;
Develop a general working knowledge of study specific and general disease pathology;
Provide logistical support;
Prepare, distribute, and file study materials (., patient binders, investigator files, pocket cards, IRB/EC packets);
Assist with preparing and coordinating internal meetings;
Attend study team meetings, take notes and assist with generating meeting minutes;
Prepare for monitoring visits including review of eTMF/CTMF (., contact sheets, licenses, annual reports, training, ;
Perform electronic data capture (EDC) administrative tasks as needed (., status changes, confirming user access, etc);
Assist CPM as needed with site and study-related documents and reports (., verification of essential documents) throughout the life cycle of the study;
Obtain and manage clinical study insurance, if applicable;
Maintain and ensure all clinical study documentation is in a state of audit-readiness; and
Provide assistance and support for other clinical study activities, as needed.
Qualifications
Associate's/Bachelor's degree (scientific-, health-, or business-related field preferred) or equivalent work experience is required;
Previous experience in supporting research or medical device/drug clinical studies is preferred;
Conscientious with a strong work ethic and personal discipline;
Conscientious with a strong work ethic and personal discipline;
Demonstrated ability to work independently and apply judgment to work on most important priorities;
Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues with a professional and personable demeanor;
Possess good computer skills with aptitude to learn new software platforms;
Experienced with standard tools, including but not limited to Microsoft Office (. Word, Excel, PowerPoint etc);
Demonstrates high level of accuracy and is detail oriented;
Strong organization skills and time management; ability to work on multiple projects;
Excellent critical thinking, computer, written, and verbal communication skills
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