Global Medical Affairs Research Grant & Study Manager

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Santen Pharmaceutical

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1001 - 5000 Mitarbeiter

💊 Pharmazie

🏥 Gesundheitswesen

🏭 Fertigung

Pharmaceuticals • Healthcare • Manufacturing

Als auf die Augenheilkunde spezialisiertes Unternehmen betreibt Santen Forschung, Entwicklung, Marketing und Vertrieb von Arzneimitteln, rezeptfreien Produkten (OTC) und Medizinprodukten. Santen ist Marktführer für verschreibungspflichtige ophthalmologische Arzneimittel in Japan, und die Produkte des Unternehmens erreichen inzwischen Patientinnen und Patienten in über 60 Ländern. Mit wissenschaftlicher Expertise und organisatorischen Kompetenzen, die in einer über 130-jährigen Geschichte gewachsen sind, bietet Santen Produkte und Dienstleistungen, die zum Wohlbefinden der Patientinnen und Patienten, ihrer Angehörigen und damit der Gesellschaft beitragen.

Beschreibung

• Serve as the operational lead for the Investigator-Sponsored Studies (ISS) and research grants process, ensuring efficient administration and governance. • Coordinate the end-to-end lifecycle of ISS and research grant activities, from submission through study close-out. • Manage study contracts, milestones, budgets, payments, reporting requirements, and maintain accurate study documentation and tracking systems. • Facilitate cross-functional collaboration with Medical Affairs, Clinical Development, Compliance, Legal, Finance, and external stakeholders to support evidence generation activities. • Coordinate the planning, execution, oversight, and close-out of Medical Affairs-sponsored evidence generation programs, including Phase IV studies, observational research, registries, and real-world evidence initiatives. • Monitor study timelines, deliverables, operational performance, and ensure studies are conducted in compliance with GCP, regulations, ethical standards, and company procedures. • Support Phase III clinical development programs and drive alignment between development activities and post-approval evidence generation strategies. • Support expanded access, compassionate use, and other special research programs, ensuring appropriate coordination, documentation, and tracking. • Oversee external vendors and CROs, monitoring performance, quality, timelines, and budget adherence while proactively identifying and mitigating operational risks. • Contribute to process improvements, SOP development, inspection readiness, and initiatives that enhance operational efficiency, compliance, and transparency across evidence generation programs.

🎯 Anforderungen

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related scientific discipline (advanced degree preferred). • Minimum 5–8 years of experience in Clinical Research, Medical Affairs, Clinical Operations, Clinical Development, or Evidence Generation. • Experience managing clinical studies, including investigator-sponsored studies (ISS), Phase III/IV, observational, or post-marketing research. • Experience coordinating research grants and investigator-sponsored studies is highly preferred. • Strong knowledge of GCP, ICH guidelines, clinical research regulations, and compliance requirements. • Proven project management skills with the ability to manage multiple priorities and collaborate effectively with cross-functional stakeholders. • Experience working with CROs, investigators, academic institutions, and external research partners in a global environment. • Strong analytical, organizational, communication, and problem-solving skills, with a high level of attention to detail. • Proficiency with clinical trial management systems, grants management systems, electronic document management systems, and Microsoft Office.

🏖️ Vorteile

• Competitive Salary: A market‑aligned base salary starting from 78.863 GBP – 108.436 GBP, depending on experience and location.