Business Operations Specialist - Study Start Up

Astellas Pharma - Northbrook, IL

Full-time - Entry Level

Remote - Northbrook, IL

Management of Companies and Enterprises

About the position

The Business Operations Specialist - Study Start Up at Astellas Pharma plays a crucial role in supporting the Clinical Operations Excellence (COE) team by managing and tracking site activations for clinical trials. This position requires a strong understanding of Study Start Up (SSU) activities and compliance with regulatory guidelines, ensuring efficient operations and communication with stakeholders to meet project goals.

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.
• Communicate and coordinate with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.
• 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, including oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager.
• Implement the SSU Strategy for assigned region during the study start up period.
• Build relationships with internal counterparts and site staff to support successful site activation strategies.
• Project site activation timelines and appropriately escalate when things get off track.
• Adhere to processes and tools designed 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.
• Handle ICF negotiations and facilitate any required escalations.
• Prepare and submit IMP Release Packages.
• Maintain 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