Astellas Pharma Inc.

• 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.
• You 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.
• The role will be site facing and support the global SSU team by efficiently managing and tracking assigned site activations.
• You will provide administrative support related to various clinical systems/technology utilized by Clinical Operations.
• The position has no direct reports.

• 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.
• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials.
• Support implementation of standards for global SSU team.

• 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.

• A BS/BA degree or Associates degree.
• Proven experience in the health care field or direct clinical trial related experience.
• Demonstrable study start-up / site activation / or an in-house CRA / in-house monitoring experience.
• Experience with CTIS system and EU-CTR (part 2).
• Must be proficient in the French and English language.
• Any additional European language such as Italian or Spanish or German speaking is advantageous.
• Must have knowledge of clinical trial conduct
• General knowledge of drug development and ICH/GCP guidelines
• Proven project management skills
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Minimal (0-5%) travel required

• Demonstrable study start-up / site activation experience in more than one country is advantageous.

• Global collab
• sions.

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

Careers | Astellas