Clinical Trial Associate

 

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 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 Medical Affairs Head of Evidence Generation Operations and Study Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned studies, which may include company-sponsored research (interventional, non-interventional, and HEOR studies), Collaborative Research, and Investigator-Sponsored Research.

 

This position is accountable to the clinical study team for the support of the study execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of study processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of study deliverables.

 

Essential Job Responsibilities:

 

Support the day-to-day operations of assigned studies 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 study information within relevant tracking systems and provide regular updates as requested to study team and other defined stakeholders Participate in the development of core study documents and study level plans, as requested Participate in or lead study 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 CRO and vendor set-up and management during clinical study execution, as requested by study manager Participate in or facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Ensure quality and completeness of TMF for assigned clinical studies Participate in study team meetings and manage associated documentation as requested