Business Operations Associate - Study Start Up Specialist

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

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.