Study Manager, Global Study Operations (Also open in UK)

Location:  San Rafael, California Category: Clinical

Hiring Manager: Katie Thomas ([email protected]), Lona McDonald ([email protected])

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Description

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.

The BioMarin Global Study Operations (GSO) 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 Summary
For assigned study(ies), the Study Manager (SM) is accountable for day-to-day Global Study Operations study execution and related deliverables and is the primary point of contact within GSO for a study. Key responsibilities include managing risks, issues and opportunities that impact timeline, quality, and budget, overseeing the GSO study team, vendors and CRO, as well as collaborating with cross-functional representatives to execute on study deliverables. The Study Manager may be assigned to and is responsible for managing early-stage, late-stage, or post approval studies. The Study Manager will engage and collaborate with cross functional team members to drive study activities and is responsible for facilitating and leading Study Execution Team (SET) activities and meetings.
Within the role the candidate is expected to show and have proficiency and experience in the following competencies: 
 
Core: 
  • Decision Making and Problem Solving
  • Influence and Organizational Awareness
  • Agility and Proactivity 
  • Leadership
  • Communication and Collaboration 
 
Technical
  • Data Analysis and Interpretation 
  • Study Management and Execution   
  • Compliance and Quality  
  • Drug Development and Study Design  
  • Product and Therapeutic Area Knowledge  
 
Responsibilities include but are not limited to:
  • Overall study execution oversight
  • Provide leadership, guidance, and direction to GSO staff assigned to studies
  • Lead cross-functional Study Execution Team (SET) meetings
  • Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans
  • Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner
  • Provide regular study quality and progress updates to key stakeholders as needed
  • Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate
  • Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program
  • Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth
  • Other responsibilities Include:
    • Contribute to the Study protocol and Informed Consent Form (ICF) development
    • Management of GSO Study Timelines
    • Management of CRO and Vendors
    • Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)
    • Oversight of Drug / Investigational Product (IP) process
    • Management of Study Budget
    • Oversight of Feasibility, Recruitment and Enrollment
    • Oversight of Study Outcome and Data Deliverables
  • Lead or participate in program or study-specific projects that have a wider impact
  • Collaborate with study managers/cross-functional team members to implement department process change and efficiencies  
Education & Experience:
  • BA/BS/BSc
  • 5 years’ work experience in life sciences or medically related field, including at least 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO setting.



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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