b'nnnnnnnn (CW) Sr. Study Specialist CONTRACT | BioMarinnnnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn
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n BioMarin Pharmaceuticaln
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(CW) Sr. Study Specialist CONTRACT
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Location: San Rafael, United States
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Workstyle: Hybrid
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Apply
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Who We Are
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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
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About Worldwide Research and Development
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From research and discovery to post-market clinical development, our R&D 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 rare diseases.
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BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We 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. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.
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The BioMarin Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function 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.
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CONTRACT Hybrid on Tues. and Thurs. in San Rafael or remote based employee within the US. *
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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:
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Core Competencies:
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xe2x97x8f .Agility and Proactivity
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xe2x97x8f .Leadership
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xe2x97x8f .Communication and Collaboration
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Technical Competencies:
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xe2x97x8f .Study Management and Execution
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xe2x97x8f .Compliance and Quality
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xe2x97x8f .Drug Development and Study Design
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xe2x97x8f .Product and Therapeutic Area Knowledge
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Responsibilities include but are not limited to:
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xe2x97x8f .Develop study specific documentation, as delegated by the Study Manager
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xe2x97x8f .Contribute to the oversight of country and site feasibility assessment and site selection.
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xe2x97x8f .Oversight of CRO for IRB/EC related submission/approval activities
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xe2x97x8f .Oversight of essential documents for study life-cycle management
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xe2x97x8f .Develop/Oversee site and investigator training materials
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xe2x97x8f .Present at investigator meetings as assigned
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xe2x97x8f .Ensure accurate and timely study entry and updates to ClinicalTrials.gov
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xe2x97x8f .Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
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xe2x97x8f .Process documents for signature in DocuSign
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xe2x97x8f .Oversight of Clinical Trial Insurance
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xe2x97x8f .Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
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xe2x97x8f .Oversee and manage essential documents in the Trial Master File (TMF)
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xe2x97x8f .Contribute to Global Study Operations risks identification and mitigations.
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xe2x97x8f .Provide support and administrative assistance with internal and external meetings
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Education & Experience
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xe2x97x8f .BA/BS or higher in nursing, life or health sciences is preferred.. Industry or relevant experience in lieu of education is considered.
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xe2x97x8f .Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets,
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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.
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Equal Opportunity Employer/Veterans/Disabled
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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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Recruitment Fraud Alert Notice
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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.
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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.
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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.
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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you
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Equal Opportunity Employer/Veterans/Disabled
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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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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.
nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.
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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.
nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.
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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.
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