Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

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.

Essential Job Responsibilities:

• Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

• Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders

• Participate in the development of core trial documents and trial level plans, as requested

• Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data

• Participate in feasibility assessment and selection of countries and sites 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 facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables

• Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team

• Ensure quality and completeness of TMF for assigned clinical trials

• Participate in trial team meetings and manage associated documentation as requested

• Participate in data cleaning and data review activities as requested

• Participate in or lead set-up and implementation of effective investigator and site monitor training

• Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable

Quantitative Dimensions:

Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out.

Organizational Context:

Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead

Qualifications:

Required

• BA/BS degree with at least three years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience

• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring

• Requires project management skills and trial leadership ability

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability

• Fluent in English

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

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Category Clinical Operations and China Development

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

EOE including Disability/Protected Veterans