Clinical Project Manager (Remote)- Ireland based
Are you an experienced Clinical Project Manager looking for a fully remote opportunity to lead innovative clinical studies for a global med tech company? We are seeking a dedicated professional to oversee the planning, execution, and completion of clinical projects while ensuring compliance with industry regulations.
Role Overview
As a Clinical Project Manager, you will be responsible for driving clinical research initiatives from start to finish. You will collaborate with cross-functional teams to ensure projects meet budget, timeline, and regulatory requirements while maintaining the highest standards of quality and integrity.
Key Responsibilities
- Oversee and manage assigned clinical research projects, ensuring adherence to Good Clinical Practice (GCP) and applicable regulations.
- Develop and implement clinical strategies in collaboration with R&D, Quality, and other key stakeholders.
- Manage project timelines, budgets, and key deliverables to ensure study success.
- Act as the clinical subject matter expert, contributing to study design, regulatory submissions, and product approvals.
- Develop and review essential clinical study documents, including Clinical Investigation Plans (CIPs), Investigator Brochures (IBs), and Clinical Study Reports (CSRs).
- Ensure compliance with regulatory reporting requirements, such as clinicaltrials.gov and other international regulations.
- Conduct audits of Trial Master Files (TMF) and maintain Clinical Trial Management System (CTMS) records.
- Establish and maintain strong relationships with investigational sites, vendors, and external partners.
- Proactively identify study risks and implement mitigation strategies
Requirements
- Bachelor’s, Master’s, or PhD in Life Sciences, Biomedical Engineering, Medicine, or a related field.
- At least five (5) years of experience in clinical research, including three (3) years in clinical study management.
- In-depth knowledge of global clinical research regulations and GCP guidelines.
- Proficiency in Microsoft Office and clinical study management tools such as eTMF, CTMS, and CDMS.
- Strong leadership, communication, and organisational skills with the ability to manage multiple projects simultaneously.
- Analytical mindset with excellent problem-solving abilities.
- Experience with clinical studies in peripheral vascular diseases, end-stage kidney disease, or oncology is a plus.
- Previous experience with medical device studies is highly preferred.
- Familiarity with site management, monitoring, and Veeva Vault Clinical Suite is beneficial.
What’s on offer
- A fully remote position with flexibility to work from anywhere in the EU.
- The opportunity to contribute to groundbreaking clinical research.
- A collaborative and innovative work environment.
- Competitive salary and benefits package.
If you are an experienced Clinical Project Manager passionate about clinical research and looking for an exciting remote opportunity in Ireland , we encourage you to apply today! *Please note applicants must be eligible to work in Ireland without any visa restrictions.
