Study Start Up Manager

Join Astellas Pharma Inc.

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.

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.

Essential Job Responsibilities

• 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 :

Supporting ICF negotiations and escalation :