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Business Operations Manager

4 weeks ago

Northbrook, Illinois, United States Astellas Pharma Full time

Job Summary:

This role 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 to enable consistent and compliant forecasting and data collection.

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.

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.
  • 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.

Requirements:

  • BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.
  • Must have knowledge of clinical trial conduct, including, multi-center, global trials.
  • Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Requires proven project management skills and leadership ability.
  • Must have excellent interpersonal, written, and verbal communication skills, administrative skills and computer ability.
  • Fluent in English.

Preferred Qualifications:

  • Experience in working cross functionally and with external providers.
  • Experience with development & implementation of process improvement related initiatives.
  • Global Experience with site activation activities including submission requirements.

Working Environment:

Astellas Pharma is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans