Astellas Pharma · 1 month ago
Business Operations Manager – Site Monitoring Strategy Training and Oversight
Northbrook, IL, 60062, United States
Full-time
Onsite
Mid, Senior LevelAstellas Pharma Inc. is a pharmaceutical company committed to developing innovative therapies for patients. The Business Operations Manager will be responsible for managing day-to-day operations within site monitoring and management, ensuring compliance with regulatory requirements, and overseeing the training and performance of Clinical Site Managers.
BiotechnologyHealth CareMedical
Responsibilities
Manage and may lead the day-to-day operations within site monitoring and management function focusing on Clinical Site Manager training and oversight to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
Manage and may lead functional and cross-functional internal teams
Proactively identify and escalate issues that arise related to support functional deliverables
Responsible for implementation of standards for designated functional areas
Responsible and may be accountable for all activities associated with relevant support function
Support internal site monitoring and management function by evolving process, developing and delivering training, developing and implementing monitoring oversight and supporting monitoring functional management
Manage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support and/or
Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab) and/or
Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or
Manage and provide operational support related to systems used by site monitoring and system/technology standards for the CO organization and/or
Management of CO QD changes and training related assignments/curriculum and staff onboarding activities
Provide oversight and direction to team members for functional and study-related deliverables
Participate in process improvement and quality-related initiatives associated with study execution and deliverables
Support and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission
Qualification
Required
Manage and may lead the day-to-day operations within site monitoring and management function focusing on Clinical Site Manager training and oversight to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and may lead functional and cross-functional internal teams
Proactively identify and escalate issues that arise related to support functional deliverables
Responsible for implementation of standards for designated functional areas
Responsible and may be accountable for all activities associated with relevant support function
Support internal site monitoring and management function by evolving process, developing and delivering training, developing and implementing monitoring oversight and supporting monitoring functional management
Manage Clinical Operations Compliance related activities inclusive of holistic evaluation of CO related audit findings, execution of CAPA and process related effectiveness checks, and CO inspection readiness support
Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab)
Manage the sustainability and optimization of internal and external business process standards for Clinical Operations
Manage and provide operational support related to systems used by site monitoring and system/technology standards for the CO organization
Management of CO QD changes and training related assignments/curriculum and staff onboarding activities
Provide oversight and direction to team members for functional and study-related deliverables
Participate in process improvement and quality-related initiatives associated with study execution and deliverables
Support and implement Study Start Up activities including global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
Founded in 2005
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase