Business Operations Manager - Study Start Up

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 as an 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 deep understanding of global site activation requirements and data flows across Astellas applications and reporting tools. The Business Operations Manager will represent Clinical Operations both early and late on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across various therapeutic areas, trial designs, and global requirements to support development of robust functional requirements for new or enhanced applications and reports. This role will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions used for clinical systems. This role will work with business process and system owners to define user roles, permissions, and training requirements.

This position may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.

Responsibilities & Accountabilities:

• Manage and may lead the day-to-day operations within Study Start Up 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.


• Manage and may lead functional and cross-functional internal teams.


• 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 functional deliverables.


• Responsible for implementation of standards for designated functional areas.


• Provide oversight and direction to team members for functional and study-related deliverables.


• Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines, and resources. May also provide oversight for these activities.


• Responsible and may be accountable for all activities associated with Study Start Up. This may include:
  
  
  
  • Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements.
  
  
  • Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period.
  
  
  • Building relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU.
  
  
  • Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
  
  
  • Contributing to process and tool development 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.
  
  
  • Supporting ICF negotiations and escalation.
  
  
  • Review and Approval of IMP Release Packages.