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Business Operations Manager – Site Monitoring Strategy Training and Oversight

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position is responsible for the execution of assigned responsibilities within the relevant Clinical Operations support function for both early and late-stage Clinical Operations.

Clinical Operational Excellence (COE) supports functions in scope for this position and may include:

+ Clinical Compliance

+ Site Monitoring and Management

+ Business Operations includes department performance management, metrics, enhancement, and departmental communication strategy & management

+ Process, Training & Development

+ Trial Master File

+ Clinical Operational Standards

+ Clinical Systems standards and management

+ Site Start Up and Activation

+ Country and Site Feasibility

+ Accountable for management of budgets, timelines, and workload

Reports to the Business Operations Lead, Clinical Operational Excellence or above. This position may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.

Essential Job 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.

This may include:

+ 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.

Qualifications

Required:

+ BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.

+ >5 years site monitoring or site monitoring oversight experience

+ Proven skillset in developing and delivering training via various methods

+ Must have knowledge of clinical trial conduct, including multi-center, global trials.

+ Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

+ Requires proven project management skills and leadership ability

+ Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

+ Fluent in English.

+ Willingness to travel nationwide up to 30% required.

Preferred:

+ Experience in working cross functionally and with external providers.

+ Experience with development & implementation of process improvement related initiatives.

**Salary Range:** $122,500-175,000 (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._

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Category Site Activation / Late-Stage Management

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans