job title: clinical trial specialist(astellas)

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

Category

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans