Clinical Project Manager

Job title:

Clinical Project Manager

Company:

FRS Recruitment

Job description

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 OverviewAs 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.

Expected salary

Location

Dublin

Job date

Tue, 18 Feb 2025 23:34:06 GMT

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