What are the responsibilities and job description for the Study specialist ii position at BIOMARIN?
Who We Are
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors.
Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Responsibilities include but are not limited to :
Develop and / or review study specific documentation, as delegated by the Study ManagerContribute to the management of country and site feasibility assessmentProvide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sitesContribute to the collection and oversight of essential documents for study life-cycle managementContribute to the development of site and investigator training materialsMay present at investigator meetings as assignedEnsure timely study entry and updates to ClinicalTrials.
govEnsure 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 warrantedFacilitate Screening Authorization Forms tracking / sign off where applicableManage various Global Study Operations document translations as applicableProcess documents for signature in DocuSignSite management for delegated site(s)Manage and resolvesite related issues and risks escalated to BioMarin that can’t be resolved by CRO.
Contribute to identifying risks identification and mitigationsOversee the Clinical Trial Insurance processSupport Study Manager to ensure timely delivery and handling of IP to the sitesSupport Vendor ManagementAttend internal Global Study Operations team meetings, vendor meetings, and / or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
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 meetingsAssist with filing GSO internal study documents in internal systemsSkills
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 ProactivityCommunication and CollaborationTechnical competencies :
Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area KnowledgeEducation
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.)In the U.S, the hiring range for this position is *51* to *75* per hour.
The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Equal Opportunity Employer / Veterans / Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S., the salary range for this position is $ null to $ null per year, which factors in various geographic regions.
The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
A discretionary bonus and / or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and / or other benefits, dependent on the level and position offered.#J-18808-Ljbffr
Last updated : 2024-04-05