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Clinical Operations Study Manager

Location London, United Kingdom Workstyle Open to Hybrid

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 will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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. Come join our team and make a meaningful impact on patients’ lives.

The BioMarin Global Clinical Operations (CLO) 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 team 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.  

The Study Manager is accountable for day-to-day Clinical Operations study execution and related deliverables and is the primary point of contact within Clinical Operations and cross-functionally for the execution of a study. The Study Manager drives cross-functional execution of study deliverables meeting timeline, budget, and quality expectations. The Study Manager is responsible for vendor and CRO oversight as assigned and manages risks, issues, and opportunities.  

Studies vary significantly in type and complexity over the lifecycle of a program. Typically, a Study Manager will be assigned the management of smaller, less complex study or studies. As they gain experience, they may take on more complex studies. The Study Manager may also support the Clinical Program Lead (CPL) in program wide activities and may gain experience engaging with leadership and leading Study Execution Team activities if assigned. 

Key study execution responsibilities for the study manager:

  • Participate as a key member of the Study Execution Team (SET): primary contact for both CLO staff and cross functional SET members for the discussion, analysis and escalation of decisions, issues and risks related to study execution
  • Communicate, collaborate with cross-functional SET members to share issues, risks, decisions, and practices that may impact deliverables, timeline, quality, and budget, and escalate with the function as appropriate
  • Provide input and guidance on operational considerations to protocol development, as appropriate
  • Develop a deep understanding of the study protocol and serve as protocol SME for assigned study or studies to all Clinical Operations team members and relevant cross functional SET members
    • Develop the Clinical Operations study specific timelines including start up, enrollment, maintenance, and close-out; ensure study-specific timelines are aligned with program level timelines; proactively identify and resolve timeline discrepancies or misalignment with peers and cross functional stakeholders
    • Hold cross-functional team members accountable for achieving cross functional deliverables according to agreed timelines
    • Understand and follow vendor oversight playbook from the selection of vendors, oversight and management, issue escalation, and financial management.
    • Lead country and site feasibility assessment and select qualified sites to participate in the study
    • Regularly review key study metrics (such as Study Quality Metrics and KPIs) to review, inquire and ensure study execution performance meets expected quality standards
    • Identify barriers to enrolment and support recruitment and retention strategic solutions
  • Facilitate key data cleaning activities throughout the study and in the lead up to database lock
  • Manage, or delegate the management, of TMF filing of Clinical Operations study documentation
  • Manage overall study budget and monitor budget adherence 

The successful candidate has the following characteristics:

  • Able to manage study budgets, including applying financial concepts to effective budget management 
  • Familiar with site management, including an ability to build relationships with sites 
  • Demonstrates robust knowledge of GCP guidelines and their impact on each stage of the trial
  • Demonstrates understanding of clinical trial data flow from patient events to database outputs
  • Demonstrates in-depth understanding of cross-functional interdependencies and potential conflicts across the drug development lifecycle
  • Demonstrates command of country-specific, regional, and global variations in regulations and guidelines
  • Effective decision-making skills, including identifying relevant stakeholders and soliciting feedback when gathering facts about problems, issues, risks, or opportunities
  • Track record of garnering support from peers and positively influencing outcomes, decisions, or group direction
  • Consistently anticipates risks or issues and takes the necessary steps to mitigate or address
  • Skilled at adjusting to and communicating updated work priorities to meet changing goals or tasks and encouraging others to do the same 
  • Consistently demonstrates an ability and eagerness to actively contribute to team efforts in a positive and constructive manner, including by taking on a leadership role when needed
  • Consistently communicates in a clear, timely, practical manner
  • Able to facilitate smaller functional team meetings with a defined topic, including preparation, agenda setting, and maintaining an active role in keeping participation on track

The Manager will be an individual contributor and will not require any people management. This position will contribute to and make an impact on project or study team outputs.

EDUCATION

  • BA/BS degree with a focus on life sciences, nursing, or related technical or scientific discipline

EXPERIENCE

  • 6+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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London

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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