Senior Manager, Clinical Operations

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Fresenius Kabi

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Fresenius Kabi is a global healthcare company specializing in lifesaving medicines and medical technologies. They provide high-quality IV drugs and infusion therapies, medical nutrition (parenteral and enteral), medtech devices for anesthesia, blood donation and cell therapies, and biopharmaceuticals for autoimmune diseases and cancer. The company emphasizes quality, sustainability, global presence and support for healthcare professionals and patients worldwide.

📋 Description

• Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas. • Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services. • Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations. • Lead cross-functional teams and drive oversight of CRO’s and vendor management. • Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.) • Responsible for inspection readiness. • Accountable for CAPAS related to clinical programs within the field of Clinical Operations. • Accountable and responsible for the financial planning, budget, accruals, forecasts contribution. • Preparing clinical program updates and/or contribution to them as needed.

🎯 Requirements

• Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background • At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management • Understanding GxP and global requirements • Strong project management skillsets • Excellent communication skills and ability to manage cross functional teams • Ability to deal with complex situations and drive solution orientated thinking • Fluent in English • Excellent team player, ability to work under high pressure and pronounced resiliency • Experience working in an international and cross-functional team • Ability to present and defend the perspective • Experienced in Microsoft project, Excel, Power point

🏖️ Benefits

• Health insurance • Professional development