Senior Clinical Research Associate II

🔥 12 hours ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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