Senior Clinical Research Associate – m/f/d

🔥 17 hours ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Function operationally as a member of a Project Team • Initiate, monitor on-site and/or remotely, and close out study sites during study conduct • Monitor clinical trials according to company and sponsor SOPs, GCP, ICH guidelines, and applicable regulations • Perform monitoring activities to assess subject safety, data integrity, and quality • Verify informed consent procedures and protocol compliance • Review CRFs and subject source documentation for validity and accuracy • Verify management and accountability of Investigational Product • Prepare Monitoring Visit Reports, document findings and corrective/preventive actions, update tracking systems, and escalate issues • Provide sites with identified issues and required action items • Deliver site documents to eTMF or paper TMF and verify Investigator Site File maintenance • Participate in audit or inspection preparation and follow-up • Order, ship, and reconcile clinical investigative supplies when applicable • Update CTMS and other project systems with accurate site-level information

🎯 Requirements

• Bachelor’s Degree, preferably in life science or nursing; or equivalent • Over 1 year of relevant clinical experience or relevant academic background around clinical trial or clinical development activities • Ability to work in a fast-paced environment with changing priorities • Understanding of basic medical terminology and science associated with assigned drugs and therapeutic areas • Understanding of Good Clinical Practice regulations and ICH guidelines • Ability to work independently and in a team matrix organization • Strong written and verbal communication skills • Fluent in English and German • Excellent organizational skills • Technology savvy with good software and computer skills • Ability and willingness to travel up to 60–80%, overnight and abroad if applicable

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Team focused on making a difference in patients' lives

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