Clinical Research Associate, Cell Therapy – Western Germany

🔥 10 minutes ago

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-02

Healthcare • Biotechnology • Pharmaceuticals

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. It primarily works in areas of oncology, cardiovascular, renal & metabolism, and respiratory diseases. With operations in over 100 countries, AstraZeneca is dedicated to scientific research and a commitment to providing effective treatments and improving patient health across a wide array of conditions.

📋 Description

• Monitoring clinical trials in cell therapy (e.g., CAR-T, TCR-T, Treg) • Ensuring correct, complete and timely transmission of study data and documents • Active involvement in all study phases (feasibility, set-up, recruitment, maintenance, DBL [database lock], closure) • Timely preparation of high-quality monitoring visit reports and follow-up letters • Use of relevant study systems such as WBDC and IVRS, and maintenance of the CTMS • Participation in international study team meetings and investigator meetings • Contributing to site selection and assessment of recruitment potential • Initiation of study sites, training, support and guidance of site staff • Monitoring recruitment performance, site performance and quality, and escalating deficiencies to study management • Proactive communication with study sites and the local study team

🎯 Requirements

• Degree in a scientific or medical discipline or equivalent • Proven prior experience as a monitor in clinical trials involving cell therapy (e.g., CAR-T, TCR-T, Treg) • Interest in modern monitoring approaches such as Risk-Based Quality Management and remote monitoring • Excellent ICH-GCP knowledge • Knowledge of applicable laws (AMG) and regulatory requirements • Good understanding of medical issues • Understanding of various study and process requirements and the ability to derive the correct priorities • Experience monitoring electronic Case Report Forms (Web-Based Data Capture) • Experience preparing monitoring reports • Excellent German and English skills • Structured, independent organization as well as analytical and solution-oriented thinking • Strong teamwork skills and excellent communication abilities • Willingness to travel, including overnight stays • Complete application including cover letter, CV and relevant certificates • Prior experience in cell therapy must be clearly and structurally presented in the CV

🏖️ Benefits

• Individual development opportunities and a focus on lifelong learning • A high-trust, appreciative environment with room to contribute ideas in a focused, passionate team • Office space in the heart of Hamburg that enables collaborative, flexible and agile working • A diverse, inclusive and non-discriminatory work environment • A sustainable company committed to becoming carbon-negative across the entire value chain by 2030