BioMarin Pharmaceutical
(CW) Senior Study Specialist
BioMarin Pharmaceutical, San Rafael, California, United States, 94911
Who We Are
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.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.
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). This may include contributing to and/or supporting study‑related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities
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 risks 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 is preferred (industry or relevant experience in lieu of education is considered)
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets
Note: This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.
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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.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.
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). This may include contributing to and/or supporting study‑related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities
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 risks 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 is preferred (industry or relevant experience in lieu of education is considered)
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets
Note: This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.
#J-18808-Ljbffr