Business Operations Manager - Study Start Up

Astellas Pharma - Northbrook, IL

Full-time - Mid Level

Remote - Northbrook, IL

Management of Companies and Enterprises

About the position

The Business Operations Manager - Study Start Up at Astellas Pharma is responsible for overseeing and managing the day-to-day operations of Study Start Up (SSU) activities within Clinical Operations Excellence (COE). This role requires expertise in clinical systems and global site activation requirements, ensuring compliance with regulatory guidelines while driving timely completion of study objectives. The manager will collaborate with cross-functional teams, define operational standards, and provide oversight to team members, contributing to the development of robust functional requirements for clinical applications.

Responsibilities

• Manage and lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Manage and lead functional and cross-functional internal teams.
• Provide accurate and up-to-date project status and financial information within relevant tracking systems/tools.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Responsible for implementation of standards for designated functional areas.
• Provide oversight and direction to team members for functional and study-related deliverables.
• Accountable for functional budgets and resources and responsible for the management of related components of trial or support function budgets, timelines, and resources.
• Responsible for all activities associated with Study Start Up, including oversight of SSU activities from receipt of a potential site list to site activation.
• Facilitate the development of the SSU Strategy and ensure management of the strategy during the study start up period.
• Build relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU.
• Drive site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
• Contribute to process and tool development to support the SSU team with day-to-day activities.
• Lead the preparation of study level essential document templates.
• Aid in the preparation of content for Regulatory submissions.
• Support ICF negotiations and escalation.
• Review and Approval of IMP Release Packages.

Requirements

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

Nice-to-haves

• Experience in working cross functionally and with external providers.
• Experience with development & implementation of process improvement related initiatives.
• Global Experience with site activation activities including submission requirements.

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