Senior Manager, Clinical Management

🕒 June 29

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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.

🎯 Requirements

• 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%.

🏖️ Benefits

• 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