Business Operations Manager, Study Start Up

2 weeks ago

Addlestone, United Kingdom Astellas Europe Full time

About Astellas Europe

Astellas Europe is a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors, and healthcare professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.

The Opportunity

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 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.

Key Responsibilities

  • Manage and 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.
  • 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.
  • Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
  • Leading the preparation of study level essential document templates.
  • Aiding in the preparation of content for Regulatory submissions.

Requirements

  • Solid knowledge of clinical trial conduct, including multi-center, global trials.
  • Strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Proven project management skills and leadership ability.
  • Experience in pharmaceutical-related drug development.
  • Excellent interpersonal, written, and verbal communication skills, administrative skills, and computer ability.
  • Good command of English.

Preferred Qualifications

  • Involved in working cross-functionally and collaborating with external providers.
  • Engaged in the development and implementation of process improvement initiatives.
  • Global experience with site activation activities, including submission requirements.

What We Offer

  • A challenging and diversified job in an international setting.
  • Opportunity and support for continuous development.
  • Inspiring work climate.

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