Job Title: Study Specialist II
The company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. They target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. The company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative the company's therapeutics, advancing the standard of care, and providing personalized support and services globally. The Company's Global Study Operations organization is tasked with providing strategic direction on the feasibility, design, and conduct of Phase 1-4 and post approval studies and drives the delivery of high-quality data to support the registration approval and post approval activities of our clinical development assets. The organization achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Summary
The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:
Core Competencies:
● Agility and Proactivity
● Communication and Collaboration
Technical competencies:
● Study Management and Execution
● Compliance and Quality
● Drug Development and Study Design
● Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
● Develop and/or review study specific documentation, as delegated by the Study Manager
● Contribute to the management of country and site feasibility assessment
● Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites
● Contribute to the collection and oversight of essential documents for study life-cycle management
● Contribute to the development of site and investigator training materials
● May present at investigator meetings as assigned
● Ensure timely study entry and updates to ClinicalTrials.gov
● Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)
● Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted
● Facilitate Screening Authorization Forms tracking/sign off where applicable
● Manage various Global Study Operations document translations as applicable
● Process documents for signature in DocuSign
● Site management for delegated site(s)
● Manage and resolve site related issues and risks escalated to BioMarin that can't be resolved by CRO.
● Contribute to identifying risks identification and mitigations
● Oversee the Clinical Trial Insurance process
● Support Study Manager to ensure timely delivery and handling of IP to the sites
● Support Vendor Management
● Attend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as reqested.
● Oversee and manage essential documents in the Trial Master File (TMF)
● Contribute to Global Study Operations risks identification and mitigations.
● Provide support and administrative assistance with internal and external meetings
● Assist with filing GSO internal study documents in internal systems
Education & Experience
● BS or higher in nursing, life or health sciences is preferred
◦ Industry or relevant experience in lieu of education may be considered
● Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
