Astellas Pharma Inc
Purpose and Scope
The Business Operations Manager will sit within Clinical Operations Excellence (COE) and serve as an expert in Study Start Up (SSU) activities and strategy. They will provide deep understanding of global site activation requirements and data flows across Astellas applications and reporting tools, and represent Clinical Operations on cross‑functional initiatives and systems implementation teams to articulate clinical trial business process requirements. Essential Job Responsibilities
Manage day‑to‑day operations within SSU to ensure completion of goals and objectives in compliance with GCP/ICH guidelines. Lead functional and cross‑functional internal teams, and maintain accurate project status and financial information. Proactively identify and resolve issues related to functional deliverables, and provide oversight and direction to team members for functional and study‑related deliverables. Accountable for functional budgets and resources, managing trial budgets, timelines, and resources, and providing oversight for related activities. Oversight of SSU activities from site list to activation, including questionnaire collection, site selection, IRB/EC submissions, and site activation requirements. Lead the preparation of study level essential document templates, and support ICF negotiations and escalation. Qualifications
Required:
Minimum BA/BS degree with ≥5 years of experience in pharmaceutical drug development. Knowledge of clinical trial conduct, including multi‑center global trials. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proven project management skills and leadership ability. Excellent interpersonal, written and verbal communication skills, administrative skills, and computer ability. Fluent in English. Minimal (10‑15%) travel required. Preferred:
Experience working cross‑functionally with external providers. Experience with development and implementation of process improvement initiatives. Global experience with site activation activities and submission requirements. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, national holidays and Summer/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 Location
Northbrook, Illinois (Remote work from certain states may be permitted). Employment Type
Full‑time Legal Notice
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
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The Business Operations Manager will sit within Clinical Operations Excellence (COE) and serve as an expert in Study Start Up (SSU) activities and strategy. They will provide deep understanding of global site activation requirements and data flows across Astellas applications and reporting tools, and represent Clinical Operations on cross‑functional initiatives and systems implementation teams to articulate clinical trial business process requirements. Essential Job Responsibilities
Manage day‑to‑day operations within SSU to ensure completion of goals and objectives in compliance with GCP/ICH guidelines. Lead functional and cross‑functional internal teams, and maintain accurate project status and financial information. Proactively identify and resolve issues related to functional deliverables, and provide oversight and direction to team members for functional and study‑related deliverables. Accountable for functional budgets and resources, managing trial budgets, timelines, and resources, and providing oversight for related activities. Oversight of SSU activities from site list to activation, including questionnaire collection, site selection, IRB/EC submissions, and site activation requirements. Lead the preparation of study level essential document templates, and support ICF negotiations and escalation. Qualifications
Required:
Minimum BA/BS degree with ≥5 years of experience in pharmaceutical drug development. Knowledge of clinical trial conduct, including multi‑center global trials. Strong knowledge of ICH/GCP guidelines and regulatory requirements. Proven project management skills and leadership ability. Excellent interpersonal, written and verbal communication skills, administrative skills, and computer ability. Fluent in English. Minimal (10‑15%) travel required. Preferred:
Experience working cross‑functionally with external providers. Experience with development and implementation of process improvement initiatives. Global experience with site activation activities and submission requirements. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, national holidays and Summer/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 Location
Northbrook, Illinois (Remote work from certain states may be permitted). Employment Type
Full‑time Legal Notice
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
#J-18808-Ljbffr