Purpose and Scope:

This position sits within Clinical Operations Excellence (COE) and serves a local expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g., CTMS) to enable consistent and compliant forecasting and data collection. They will have a good understanding of their local SSU processes and requirements. The Business Operations Associate will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) by adhering to standard operational terminology and data conventions used for clinical systems. This role will be site facing and support the global SSU team by efficiently managing and tracking assigned site activations.

Provide administrative support related to various clinical systems/technology utilized by Clinical Operations. This position has no direct reports.

Responsibilities and Accountabilities:

• 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. This includes effective communication and coordination 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 (where appropriate) 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
• This may include:
  • Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
  • 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 the support of 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
• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.

Required Qualifications:

• BS/BA degree or Associates degree with 6gt;=2 years of experience in the health care field or direct clinical trial
• related experience.
• Must have knowledge of clinical trial conduct
• General knowledge of drug development and ICH/GCP guidelines
• Requires proven project management skills
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English.
• Minimal (0-5%) travel required

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines and international stakeholders

• Highly matrixed environment requiring cross-regional coordination.
• Frequent interaction with senior leadership and governance bodies.
• Collaboration across EU, US, and Japan time zones.

Salary Range

$93,100 - $133,000 (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 provided applies to US only and does not apply to any other locations outside of the US

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 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
• Company fleet vehicle for eligible positions
• Referral bonus program

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