Senior Manager, Clinical Management

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

💊 Pharmazie

🏥 Gesundheitswesen

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.

Beschreibung

• Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. • Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. • Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. • Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. • Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. • Participate in forecasting study expenditures and resourcing needs. • Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. • Provide timely communication of any variances in budget forecast to the Director/Associate Director. • Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. • Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. • Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. • Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. • Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. • Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. • Represent Clinical Management in departmental and cross-functional initiatives, as assigned. • Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. • May have supervisory responsibilities including: coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. • Performs other duties, as assigned.

🎯 Anforderungen

• Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. • Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). • Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. • Strong understanding of global regulatory requirements. • Strong communication, organization, planning, analytical, problem solving, and people management skills. • Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) • Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). • Ability to travel up to 25%.

🏖️ Vorteile

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits