Clinical Trial Specialist

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

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 all global 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 directly to Clinical Operations Functional Head or Manager, or Clinical Operations Lead.

Responsibilities and Accountabilities:

• Support the day-to-day operations with a high sense of urgency for 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 collaborating closely with other non-regional CTS team members to ensure 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 and implementation 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.