Title:  Clinical Trial Specialist

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Purpose and Scope

This position will assist the Clinical Trial Lead (s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution and close-out of assigned drug trials, which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the clinical trial team for the support of the trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.

Role and Responsibilities

• Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team objectives, milestones and deliverables, in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Responsible for ensuring maintenance of accurate and up-to-date trial information within relevant tracking systems and providing regular updates as requested to trial team and other defined stakeholders.
• Participate in the development of trial plans and system set-up including implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
• Participate in site feasibility assessment and maintenance of associated data for trial conduct.
• Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
• Participate in or lead TMF set-up and maintenance to ensure quality and completeness.
• Participate in trial team meetings and manage associated documentation as requested.
• Participate in coordination of data cleaning and data reviews as requested.
• Participate in set-up and coordination of investigator and site monitor training, as appropriate.
• Participate in the coordination of patient-focused strategies for assigned trials, as appropriate.
• Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out.

Required Qualifications

Preferred Qualifications

• Must have BA/BS degree or Associates degree with at least 2 years of experience in the health care field.
• General knowledge of drug development and ICH/GCP guidelines.
• Fluent in English (oral and written).
• Minimal (0-5%) travel required.

Working Environment

Location

This position is based in Mexico and will require on-site work in a hybrid set up.