Clinical Trial Associate (Study Start Up)

Mô tả công việc

Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are breakthrough products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.Alkermes is in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people.Description:Position Summary: Project support: Responsible for coordination, logistics, tracking and administrative tasks in support of clinical study start up. Operational support: Responsible for special projects supporting departmental operations.Duties and Responsibilities: Clinical project team member: works closely with the Associate Director, Study Start Up and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical study start up.Supports and tracks study start up status and metrics, for assigned clinical projects.Responsible for data entry into Clinical Trial Management Systems, including Investigator databases, and/or other systems as required.Supports and/or tracks external access rights to Clinical Trial Management Systems. Interacts with CROs, vendors, clinical sites, monitors and other external partners to provide information and resolution for specific requests and issues.In conjunction with clinical operations team, manages and tracks clinical and non-clinical supplies required for distribution during study start up.In conjunction with clinical project team, responsible for review of regulatory documents and verification of other items required to initiate drug shipment.Assists with and/or responsible for agendas and meeting minutes for clinical start up meetings.Assists with logistics coordination for investigator meetings and external vendor meetings, as needed.Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts as directed.Responsible for review of site- and/or country-specific clinical trial budgets, with supervision by Associate Director, Study Start Up and/or clinical project team.Research country-specific clinical trial laws and regulations, upon request, in order to provide resources or information to Associate Director Study Start up and/or clinical project team.Coordinate with clinical operations project team on set-up of Trial Master File systems.Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act etc.Education/Skills and Experience Requirements for CTA level:Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred Experience: 1-2 years clinical research experience in a pharmaceutical/biotech, CRO setting preferredBasic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trialsStrong interpersonal, organizational, and multi-tasking skills Excellent attention to detail and problem solving skillsSelf-motivated and displays initiativeAdaptable to changing priorities, excels in fast-paced environmentPerform job duties with minimal supervision and guidanceAbility to work effectively work in a team settingEducation/Skills and Experience Requirements for Sr. CTA level:Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience Experience: minimum 5 years clinical research experience in a pharmaceutical/biotech, CRO setting Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trialsStrong interpersonal, organizational, and multi-tasking skills Excellent attention to detail and problem solving skillsSelf-motivated and displays initiativeAdaptable to changing priorities, excels in fast-paced environmentPerform job duties with minimal supervision and guidanceAbility to work effectively work in a team settingPhysical Demands and Work Environment:● Travel domestic and international – minimal 0-5%Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.