Business Operations Specialist - Study Start Up

Astellas Pharma - Northbrook, IL

Full-time

Remote - Northbrook, IL

Management of Companies and Enterprises

About the position

The Business Operations Associate position at Astellas Pharma Inc. is focused on supporting Study Start Up (SSU) activities within Clinical Operations Excellence (COE). This role involves managing and tracking site activations, ensuring compliance with regulatory requirements, and providing administrative support related to clinical systems. The position is site-facing and requires effective communication with stakeholders to achieve project goals and objectives.

Responsibilities

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Generate and 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 SSU deliverables.
• Effectively execute against assigned activities within SSU.
• Support implementation of standards for global SSU team.
• Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager.
• Implementation of the SSU Strategy for assigned region during the study start up period.
• Building relationships with internal counterparts and site staff to support successful site activation strategies.
• Projecting site activation timelines and appropriately escalating when things get off track.
• Adhering to process and tools designed to support the SSU team with day-to-day activities.
• Leading the preparation of study level essential document templates.
• Aiding in the preparation of content for Regulatory submissions.
• Handling ICF negotiations and facilitating any required escalations.
• Preparation and submission of IMP Release Packages.
• Maintaining accurate and timely information in relevant clinical systems.

Requirements

• BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.
• Knowledge of clinical trial conduct.
• General knowledge of drug development and ICH/GCP guidelines.
• Proven project management skills.
• Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.

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