Clinical Trial Specialist

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 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.

Required Qualifications

• Must have BA / BS degree with at least two years of clinical trial experience in health care field.
• Must have excellent interpersonal, written, verbal, presentation, administrative and computer skills.
• Fluent in English (oral and written)
• General knowledge of clinical protocol & drug development processes, clinical trial phases, and ICH / GCP guidelines. is preferred.
• Minimal (0-5%) travel required

Preferred Qualifications

Working Environment

Choose one of the first two statements below to describe onsite work expectations for the role. Additional points may include travel requirements, office or laboratory working environment, highly collaborative environment, description of equipment used, etc.

Category

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

EOE including Disability / Protected Veterans

Skills Required

tracking systems , Clinical Protocol, ICH GCP Guidelines, Data Cleaning