Senior Clinical Research Associate II

🕒 il y a 17 jours

🇩🇪 Allemagne – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Pfizer

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1849

💼 Conseil

📣 Marketing

💊 Pharmaceutique

💰 Post-IPO Debt en 2023-05

Consulting • Marketing • Pharmaceuticals

Nous célébrons 175 ans d'innovation scientifique audacieuse - et nous n'avons pas encore terminé. Chaque jour, nous mettons notre passion et nos ressources au service de la mise au point de thérapies innovantes qui changent le visage des soins de santé. Surpassons hier.

Description

• Independently manage and oversee assigned clinical trial sites throughout the entire study lifecycle—from study initiation through study close-out • Ensure clinical trials are conducted in accordance with the study protocol, Monitoring Plan, regulatory requirements, and internal quality standards • Take responsibility for the timely achievement of study milestones and high quality standards at the site level • Serve as the primary point of contact for clinical trial sites throughout study conduct • Build and maintain trusted relationships with investigators and study staff • Work closely with Site Care Partners, Study Leads, and global study teams • Support recruitment and site activation activities to facilitate patient enrollment • Conduct onsite, remote, and electronic monitoring, including Site Initiation Visits, routine monitoring visits, and Close-Out Visits • Proactively identify, assess, and resolve study and quality risks • Develop and track Corrective and Preventive Actions (CAPAs) • Ensure proper documentation in study systems and Trial Master Files • Monitor Adverse Events (AEs) and Serious Adverse Events (SAEs) and collaborate with Safety functions • Ensure compliance with regulatory requirements, data privacy regulations, and Good Clinical Practice (GCP) • Support audits, inspections, and quality initiatives • Mentor and coach Clinical Research Associates and Senior Clinical Research Associates I • Provide subject-matter support for CRA-related processes • Contribute to or lead regional and global process improvement initiatives

🎯 Exigences

• University degree in Life Sciences or a comparable qualification, such as nursing, pharmacy, medicine, or a related field • At least 5 years of relevant experience in clinical trial monitoring • Experience conducting global clinical trials • Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical research processes • Strong analytical and problem-solving skills • Strong quality and compliance orientation • Ability to operate effectively and exert influence within a complex matrix organization • Excellent communication and presentation skills • Experience providing subject-matter support and developing colleagues • Fluency in German and English, both written and spoken • Experience in oncology, vaccines, internal medicine, or infectious diseases is an advantage

🏖️ Avantages

• Equal treatment and equal opportunities throughout the entire application process • Reasonable accommodations to support applications, interviews, and future career development for people with disabilities