Business Operations Specialist - Study Start Up
Astellas

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

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

Essential Job 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.
• 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.