Business Operations Associate - Study Start Up Specialist

Astellas Pharma, a global life sciences leader, is seeking a skilled professional to join its North American operations. The company focuses on delivering transformative therapies across oncology, ophthalmology, urology, immunology and women’s health, with a strong emphasis on turning innovative science into real value for patients. The role offers a hybrid work arrangement in Northbrook, IL, with the possibility to work remotely from anywhere in the US, and is ideal for someone who enjoys cross-functional collaboration and making a tangible impact on patient care.

The position is named Business Operations Associate - Study Start Up Specialist and sits within Clinical Operations Excellence. It serves as a local SSU expert, coordinating with study teams and partnering functions to enable compliant forecasting and data collection in clinical systems such as CTMS. It’s a site-facing role that supports the global SSU team by efficiently managing and tracking site activations, while upholding standard terminology and data conventions used for clinical operations. This is a non-management role with no direct reports, but it interacts frequently with internal colleagues and external site staff.

If you enjoy working in a highly collaborative, matrixed environment with a strong emphasis on integrity and impact, this could be a good fit. It’s a global position that requires cross-regional coordination and comfort working across EU, US and Japan time zones.

Starting up studies, one site at a time

In day-to-day work you’ll help keep SSU activities on track, coordinating with study teams and stakeholders to meet objectives in line with GCP/ICH guidelines and regulatory requirements. You’ll provide timely project status and, where applicable, financial information in relevant tracking tools, and you’ll proactively flag issues related to SSU deliverables for resolution. You’ll execute assigned SSU tasks and contribute to the rollout of standards for the global SSU team, helping to shape region-specific strategies during the study start-up period.

Your responsibilities may include overseeing site-level SSU activities from the receipt of a potential site list through site activation, under the guidance of a Global SSU Manager. This includes CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP release and other activation steps, plus preparing study-level essential document templates and supporting content for regulatory submissions. You’ll work to project activation timelines, escalating when things veer off track, and you’ll maintain accurate information in relevant clinical systems as you support day-to-day SSU activities and assist with the implementation of global SSU standards.

What you need to bring

• A bachelor's degree or an associate degree with at least two years of experience in the health care field or direct clinical trial work
• Solid knowledge of how clinical trials are conducted
• General understanding of drug development and ICH/GCP guidelines
• Demonstrated project management capabilities
• Strong interpersonal, written and verbal communication skills, good administrative abilities and solid computer literacy
• Fluency in English
• Minimal travel, 0–5%

Nice-to-haves

• Experience supporting site activation activities under the direction of a Global SSU Manager, including handling site activation steps and related documentation
• Familiarity with clinical systems such as CTMS and other trial tools
• Experience negotiating ICFs and assisting with regulatory submissions
• Ability to collaborate effectively across regions (EU, US, Japan) and time zones

Pay, benefits and practical details

The role is based in Northbrook, IL with a hybrid setup that blends in-office collaboration and work-from-home days in line with Astellas’ Responsible Flexibility Guidelines. The salary range for this position is $93,100 - $133,000, and final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations. The salary range applies to US applicants.

Employees at Astellas can access a broad benefits package including medical, dental and vision insurance, generous paid time off plus holidays and year-end shut down, a 401(k) match with company contributions, company-paid life insurance, and eligibility for annual corporate bonuses or quarterly incentives where applicable. There are long-term incentive plans for eligible roles, and programs such as a referral bonus contribute to a comprehensive rewards approach. The role also involves interactions across multiple disciplines in a global, cross-regional environment.

Two more notes about the work environment: this is a global role that requires collaboration across EU, US and Japan time zones, and the organization maintains a strong emphasis on work/life balance with a hybrid model designed to support both office and remote work.

Three steps to stand out for this SSU role

Put your SSU and site activation experience up front on your resume, especially any involvement with CDA collection, ICF negotiations, IRB/EC submissions, and IMP release processes. Highlight any use of CTMS or other clinical systems to forecast timelines and track data, and mention specific regulatory submission support you’ve provided. Concrete examples help show you can turn SSU plans into actionable, compliant activations.

Demonstrate how you’ve proven project management and cross-functional collaboration in a matrixed environment. Describe times you coordinated with study teams, IT or IS colleagues, and regional partners to keep activation milestones on track, including any escalation you managed and how you communicated risk to leadership.

Prepare for interviews by outlining end-to-end SSU workflows you’ve supported, and bring a few stories about building relationships with site staff that helped achieve on-time activations. Think about a question you’d like to ask, such as how the global SSU strategy is rolled out across regions and how this role interfaces with IT/IS during activations across multiple time zones.