Business Operations Manager - Study Start Up

Astellas - (Contractor) - Northbrook, IL

Full-time - Mid Level

Remote - Northbrook, IL

About the position

The Business Operations Manager for Study Start Up at Astellas Pharma plays a crucial role in overseeing and managing the Study Start Up (SSU) activities within Clinical Operations Excellence (COE). This position is responsible for ensuring compliance with regulatory requirements, facilitating site activation processes, and collaborating with cross-functional teams to support the development of innovative therapies. The role requires a deep understanding of global site activation requirements and the ability to manage both functional and cross-functional teams effectively.

Responsibilities

• Manage and lead 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.
• Communicate and coordinate with key business stakeholders to support timely completion of both drug and non-drug program goals and objectives.
• 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 related to support functional deliverables.
• Implement 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 manage related components of trial or support function budgets, timelines, and resources.
• Oversee SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements.
• 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 approve IMP Release Packages.

Requirements

• Expertise in Study Start Up (SSU) activities and strategy.
• Deep understanding of global site activation requirements and data flows across clinical systems.
• Experience in managing day-to-day operations in a clinical setting.
• Strong communication and coordination skills with key business stakeholders.
• Ability to manage functional and cross-functional teams effectively.
• Proficiency in project management and tracking systems/tools.
• Knowledge of GCP/ICH guidelines and regulatory requirements.

Nice-to-haves

• Experience with clinical trial management systems (CTMS).
• Familiarity with regulatory submission processes.
• Previous experience in a pharmaceutical or biotech environment.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Flexible work options including remote work
• Professional development opportunities
• Paid holidays and vacation time