Job Summary and Location
Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate-sponsored programs from Phase I to Phase IV. Location: Spain. Responsibilities
Plan, coordinate, oversee, and conduct complex global clinical trials in one or more therapeutic areas. Collaborate in a global environment, applying best practices and knowledge of internal and external business issues to improve processes, standards, and services. Accountable for planning, driving, and monitoring protocol-related activities throughout the project lifecycle to meet timelines, budget, and quality expectations. Lead cross-functional teams and oversee CROs and vendor management, ensuring cross-functional teams jointly achieve trial objectives and goals. Understand agency requirements related to clinical packages and plans, managing functions such as CSR, TFLs, ISS, etc. Ensure inspection readiness and manage CAPAs related to clinical programs within Clinical Operations. Accountable for financial planning, budget, accruals, and forecast contributions. Prepare clinical program updates and contribute to them as needed. Qualifications
Advance degree in life sciences (graduate degree), e.g., Biology, Chemistry, Pharmaceuticals, or a medical background. At least 7 years of experience in clinical research within industry, with at least 5 years in clinical trial management. Understanding of GxP and global requirements. Strong project management skillsets. Excellent communication skills and ability to manage cross-functional teams. Ability to handle complex situations and drive solution-oriented thinking. Fluent in English. Excellent team player, able to work under high pressure and demonstrate pronounced resilience. Experience working in an international and cross-functional team. Ability to present and defend perspectives. Proficiency in Microsoft Project, Excel, and PowerPoint. Other Tasks
Participate in relevant meetings. Plan and set up cross-functional meetings, vendor meetings, and other necessary discussions. Own and/or contribute to SOP development and reviews. Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required.
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Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate-sponsored programs from Phase I to Phase IV. Location: Spain. Responsibilities
Plan, coordinate, oversee, and conduct complex global clinical trials in one or more therapeutic areas. Collaborate in a global environment, applying best practices and knowledge of internal and external business issues to improve processes, standards, and services. Accountable for planning, driving, and monitoring protocol-related activities throughout the project lifecycle to meet timelines, budget, and quality expectations. Lead cross-functional teams and oversee CROs and vendor management, ensuring cross-functional teams jointly achieve trial objectives and goals. Understand agency requirements related to clinical packages and plans, managing functions such as CSR, TFLs, ISS, etc. Ensure inspection readiness and manage CAPAs related to clinical programs within Clinical Operations. Accountable for financial planning, budget, accruals, and forecast contributions. Prepare clinical program updates and contribute to them as needed. Qualifications
Advance degree in life sciences (graduate degree), e.g., Biology, Chemistry, Pharmaceuticals, or a medical background. At least 7 years of experience in clinical research within industry, with at least 5 years in clinical trial management. Understanding of GxP and global requirements. Strong project management skillsets. Excellent communication skills and ability to manage cross-functional teams. Ability to handle complex situations and drive solution-oriented thinking. Fluent in English. Excellent team player, able to work under high pressure and demonstrate pronounced resilience. Experience working in an international and cross-functional team. Ability to present and defend perspectives. Proficiency in Microsoft Project, Excel, and PowerPoint. Other Tasks
Participate in relevant meetings. Plan and set up cross-functional meetings, vendor meetings, and other necessary discussions. Own and/or contribute to SOP development and reviews. Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required.
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Senior Manager Clinical Operations (m/f/d) Arbeitgeber: 206030 Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf kontinuierliche Verbesserung und Mitarbeiterentwicklung fördert das Unternehmen eine Kultur des Lernens und der Zusammenarbeit, die es Ihnen ermöglicht, Ihre Fähigkeiten in einem globalen Kontext zu erweitern. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einer klaren Karriereentwicklung, die Ihre beruflichen Ziele unterstützt.
Kontaktdaten:
206030 Fresenius Kabi SwissBioSim GmbH Recruiting-Team
