Clinical Trial Specialist

About Astellas: At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results. Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values, and systems 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. Reports to Clinical Operations Functional Manager, or Clinical Operations Lead. Responsibilities and Accountabilities: 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: Must have BA/BS degree or Associates degree with at least 2 years of experience in the health care field. Must have excellent interpersonal, written, verbal, presentation administrative and computer skills. Fluent in English (oral and written). General knowledge of drug development and ICH/GCP guidelines. Fluent in English. Minimal (0-5%) travel required. Preferred Qualifications: Advanced Degree Working Environment At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Location: Mexico City, Mexico, MX

Posted Date: 7/3/2025