Senior Clinical Project Manager

🔥 6 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Lead and coordinate complex clinical projects across pharmaceutical, biotechnology, medical device, and consumer health clients • Manage project-specific Sponsor services, including central lab exams, drug shipments, and document shipments • Coordinate Sponsors, Investigators, and project team members • Manage study data documentation, including CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, and correspondence • Ensure project timelines and budgets are maintained • Monitor workload and performance of the project team • Plan and monitor team tasks • Coordinate Clinical Research Associate and Clinical Monitor activities • Collaborate on local authority approvals, biometrics, safety, regulatory, and archiving activities • Assist the Medical Monitor with protocols, Case Report Forms, and final Clinical Study Reports • Deliver project-specific training and organize Monitor, Investigator, and project update meetings • Provide project updates to Sponsors, Senior Project Managers, and Project Directors/Leaders • Escalate issues to the Project Director/Leader • Perform co-monitoring visits as necessary • Tutor Project Coordinators and Project Manager I • Maintain Sponsor relationships • Prepare SOPs for clinical research activities and enforce Company procedures

🎯 Requirements

• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; an equivalency consisting of appropriate education, training and/or directly related experience may be considered • At least 8 years of clinical research experience in Project Management • Previous experience managing respiratory, rare disease, general medicines and/or GLP-1 studies • Previous CRO experience • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements • Fluent in English • Proficiency in Microsoft Office, including Word, Excel, and Outlook • Previous CRA experience highly desirable • Prior experience in electronic data capture preferred

🏖️ Benefits

• Professional development • Strong work-life balance • Collaborative, quality-driven “one-team” culture • Continuous training and close management • Equal opportunity and inclusive workplace

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