BioSpace
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(CW) Senior Study Specialist
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BioSpace
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
About Worldwide Research And Development 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.
Role Summary The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). The role involves ensuring study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS demonstrates independence in executing assigned tasks and manages more challenging or complex vendors, sites, and regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and QualityDrug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities Include But Are Not Limited To
Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection.
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life‑cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign‑off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance
Attend Global Study Operations team, vendor, 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 risk identification and mitigations
Provide support and administrative assistance with internal and external meetings
Education & Experience
BA/BS or higher in nursing, life or health sciences preferred. Industry or relevant experience in lieu of education is considered.
Experience in a biotechnology or pharmaceutical company overseeing external vendors including SOW and budgets.
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.
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(CW) Senior Study Specialist
role at
BioSpace
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
About Worldwide Research And Development 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.
Role Summary The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). The role involves ensuring study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS demonstrates independence in executing assigned tasks and manages more challenging or complex vendors, sites, and regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and QualityDrug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities Include But Are Not Limited To
Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection.
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life‑cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign‑off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance
Attend Global Study Operations team, vendor, 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 risk identification and mitigations
Provide support and administrative assistance with internal and external meetings
Education & Experience
BA/BS or higher in nursing, life or health sciences preferred. Industry or relevant experience in lieu of education is considered.
Experience in a biotechnology or pharmaceutical company overseeing external vendors including SOW and budgets.
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.
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