Study Specialist I, Global Study Operations

1 month ago


San Rafael, California, United States BioMarin Pharmaceutical Inc. Full time

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.

THIS ROLE IS HYBRID AND REQUIRES WORKING IN SAN RAFAEL A MINIMUM OF 2 DAYS PER WEEK 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. 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. Role SummaryThe Study Specialist I (SS I) responsible to complete tasks related to the administrative support of study teams and department members and efforts. The SS I is not allocated as a resource to any specific study or program. Administrative tasks and activities may be requested by a line manager, study team member, or GSO department staff. Assignments may include contributing to or supporting teams as an ad-hoc or SWAT resource and in some cases may require line manager approval depending on level of effort and/or duration. Activities and responsibilities may include:

BOARD Quarterly MVR GSO Compliance and other metricsSRDO Program Roster updates and maintenanceGSO Department Website maintenanceKnowledge Manager; responsible for maintaining the department website, GSO Dept Teams locations, and reconciling/filing between Teams and the GSO SharePoint Content CenterThe below tasks may also be included when unsupported by study staff and/or CRO:eTMF and SharePoint/Teams documents; may include upload, correction, review, and reportingClerical assistance to arrange internal/external meetings and teleconferencesProcess documents for DocuSign signatures (e.g., facilitate and/or support IP package review/signatures, ICF signatures)Assist with tracking and review of Clinical Trial Insurance requirements, expiry dates, insurance renewal, certificate distribution, and archivalSupport mass communications via email or mailingsSkillsRelevant administrative experience including detail oriented, collaborative, positive attitude, ability to prioritize, proactive, and good follow up skills,Proficient in MS Suite; Excel, Word, Outlook, Zoom, and TeamsEducation In the U.S, the hiring range for this position is (USD)31.00 to (USD)50.00 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.

  • San Francisco, California, United States BioSpace, Inc. Full time

    Job Details At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to...

  • Study Coordinator

    2 weeks ago


    San Francisco, California, United States University of California Full time

    Study CoordinatorProctor FoundationFull-TimeJob Summary:- Collaborate with a dynamic team of researchers at UCSF Francis I. Proctor Foundation- Engage in studies on eye diseases in the U.S. and globally, including randomized controlled trials and epidemiological research on infectious and inflammatory eye conditions.- Responsibilities include contributing...


  • San Mateo, California, United States BeiGene Full time

    **Position Summary:** + Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget + Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned...

  • Study Director

    2 weeks ago


    San Francisco, California, United States Sotera Health Services, LLC Full time

    Job DescriptionJob Summary: The Study Director - Filters has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time....


  • San Francisco, California, United States Ivy Exec Full time

    Position: $300/hour Paid Market Research Study for Billing and Collections Managers in the Veterinary SectorMarket research studies are paid engagements Ivy Exec conducts with clients to get feedback on certain topics.For this study we are looking for financial professionals regarding their experience and feedback on virtual credit cards and accounts payable...


  • San Francisco, California, United States Ivy Exec Full time

    Position: $300/hour Paid Market Research Study for Billing and Collections Managers in the Veterinary SectorMarket research studies are paid engagements Ivy Exec conducts with clients to get feedback on certain topics.For this study we are looking for financial professionals regarding their experience and feedback on virtual credit cards and accounts payable...


  • San Diego, California, United States San Diego Community College District Full time

    Posting DetailsPosting Details (Default Section)Closing Date:Open Until Filled NoClassification TitleBLACK STUDIES:Adjunct / Substitute Instructor POOL (college credit)Working Title Adjunct FacultyRecruitment LimitsLocation District WidePay InformationYou may view the current salary schedule by clicking here ) .At the time that an offer of assignment is...


  • San Diego, California, United States San Diego Community College District Full time

    Posting DetailsPosting Details (Default Section)Closing Date:Open Until Filled NoClassification TitleBLACK STUDIES:Adjunct / Substitute Instructor POOL (college credit)Working Title Adjunct FacultyRecruitment LimitsLocation District WidePay InformationYou may view the current salary schedule by clicking here ) .At the time that an offer of assignment is...


  • San Diego, California, United States University of California, San Diego Full time

    Lecturer in Education StudiesPOSITION DESCRIPTIONWith a commitment to excellence and diversity the University of California, San Diego Department of Education Studies (EDS) invites applications for the position of Non-Senate Faculty (temporary/part-time lecturer) to teach undergraduate courses as well as courses in the graduate credential programs during the...


  • San Rafael, California, United States BioMarin Pharmaceutical Inc. Full time

    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. Hybrid role - 2...


  • San Rafael, California, United States BioMarin Pharmaceutical Inc. Full time

    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. Hybrid role - 2...


  • San Rafael, California, United States Harvest Technical Services, Inc. Full time

    Job DescriptionJob DescriptionHybrid: Onsite Tuesday and one additional dayDuties: Serve as BMS for one program (all studies) or select studies across multiple programs as necessary.Perform continuous tracking of clinical trials collected biospecimens and related logistics, issues, and queries from the planning stage to final disposition.Support biospecimen...


  • San Diego, California, United States University of California, San Diego Full time

    Critical Gender Studies Temporary Lecturer PoolPOSITION DESCRIPTIONThe Critical Gender Studies Program at the University of California, San Diego is committed to academic excellence and diversity within the faculty, staff and student body, and invites applicants whose experience has prepared them to contribute to our commitment.Responsibilities entail...


  • San Diego, California, United States University of California, San Diego Full time

    Critical Gender Studies Temporary Lecturer PoolPOSITION DESCRIPTIONThe Critical Gender Studies Program at the University of California, San Diego is committed to academic excellence and diversity within the faculty, staff and student body, and invites applicants whose experience has prepared them to contribute to our commitment.Responsibilities entail...


  • San Diego, California, United States University of California, San Diego Full time

    Critical Gender Studies Temporary Lecturer PoolPOSITION DESCRIPTIONThe Critical Gender Studies Program at the University of California, San Diego is committed to academic excellence and diversity within the faculty, staff and student body, and invites applicants whose experience has prepared them to contribute to our commitment.Responsibilities entail...


  • San Francisco, California, United States Golden Gate University Full time

    Adjunct Faculty, School of Undergraduate StudiesJob DetailsJob LocationSan Francisco - San Francisco, CADescriptionPosition Title: Adjunct Faculty, Undergraduate ProgramsDepartment Name: School of Undergraduate StudiesPosition Reports To: Dean of School of Undergraduate StudiesFLSA STATUS: ExemptSalary Range: $1,440 per unitBenefits: Limited University's...

  • Federal Work Study

    2 weeks ago


    San Bernardino, California, United States San Bernardino Community College District Full time

    Representative Duties: About the Position: Job Description This posting is to establish a pool of qualified applicants for the academic year. The department may not be actively recruiting. Your application will remain on file for consideration until June 30, 2024. Should the department be interested in interviewing you, you will be contacted by the...

  • Medical Specialist

    2 weeks ago


    South San Francisco, California, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Medical Specialist, working in Biotechnology/Medical Devices industry in South San Francisco, California, United States. Responsibilities: Recruits, schedules, and consents clinical study subjects Assists in the...


  • San Diego, California, United States University of California, San Diego Full time

    Lecturer in Latin American Studies AY POSITION DESCRIPTIONFor Academic Year , Latin American Studies at UC San Diego [] has occasional openings for temporary non-tenure track lecturers (Unit 18) throughout the academic year. The program is looking for applicants who have experience teaching include undergraduate lower and upper division lecture courses. The...


  • San Diego, California, United States University of California, San Diego Full time

    Lecturer in Latin American Studies AY POSITION DESCRIPTIONFor Academic Year , Latin American Studies at UC San Diego [] has occasional openings for temporary non-tenure track lecturers (Unit 18) throughout the academic year. The program is looking for applicants who have experience teaching include undergraduate lower and upper division lecture courses. The...