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Clinical Trial Manager

Location London, United Kingdom
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 Clinical Trial Manager is an essential position within Clinical Operations providing oversight of the CLO study team, vendors and CRO in support of BioMarin’s Therapeutic Area Strategy. Specifically, the Clinical Trial Manager holds the role of Study Operations Lead and is accountable for day-to-day Clinical Operations activities and deliverables associated with clinical trial execution. They serve as the primary point of contact within Clinical Operations for a study.

Note: The Clinical Trial Manager my also serve in the role of Regional Operations Lead (ROL) for a global, multi-country study. Details of the ROL role are outlined by the Study Operations Role as required by study.

Following demonstrated success in the Study Operations Lead role, the Clinical Trial Manager may have the opportunity to take on the Cross-functional Study Execution Team Lead (SETL) role for a Study Execution Team with earlier stage or lower complexity studies.                                      


Responsibilities may include, but are not limited to:


  • Establish/create the study-specific oversight plans in collaboration with Business Operations
  • Drive the development and adherence to Clinical Operations owned study specific plans
  • Ensure protocol deviation meetings are conducted per plan
  • Facilitate internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA / Quality Event (QE) input in Trackwise
  • Manage TMF filing of Clinical Operations study documentation
  • Conduct or participate in inspections readiness activities in collaboration with DSQ


  • Develop the Clinical Operations study specific timelines including start up, enrolment, maintenance and close-out

Contracts & Budgets:

  • Initiate Change Order (CO) and Change Negotiation Form (CNF) for vendors in collaboration with Business Operations
  • Ensure invoice review of vendors, track vendor spend against plan and provide vendor budget updates to SETL
  • Provide monthly accrual for vendors to SETL
  • Ensure investigator payment: site setup, pass-through processing, visit payment processing and funding processing in collaboration with DrugDev

Clinical Operations Managed Vendors & CRO:   

  • Ensure vendor oversight plan is created and maintained
  • Contribute to the selection of CRO and vendors
  • Contribute to the development of standard metrics used to routinely monitor study activities
  • Perform day-to-day management of the CRO and other vendor(s) as needed
  • Monitor all vendors/CRO performance, communicate vendor expectations, and track vendor performance metrics at a study level
  • Ensure that vendors/CRO are adequately trained to perform their functions
  • Escalate vendor/CRO issues to the SETL when appropriate

Protocol & Informed Consent Form (ICF) Development Process:

  • If assigned prior to protocol finalization, provide input to the protocol development
  • Serve as protocol subject matter expert for assigned study or studies
  • Actively contribute to the review of amendments to the protocol
  • Ensure creation and maintenance of tracker for future amendment changes
  • Contribute to the review of amendments to the ICF Master
  • Develop country/site specific ICFs
  • Ensure alignment of country/site specific ICFs with ICF Master

Study Start Up:

  • Translate study start up requirements into regional/local targets
  • Ensure development and review of study specific documentation
  • Lead country and site feasibility assessment, as appropriate
  • Select potential qualified sites to participate in the study
  • Lead confidentiality agreement execution, budget and contract negotiation with selected sites in collaboration with Legal and Business Operations
  • Ensure regulatory document collection and tracking is performed for sites participating in studies
  • Lead Institutional Review Board/Ethics Committee (IRB/EC) related activities from submission to approval
  • Confirm that all site level documents have been collected to support site initiation
  • Lead process for the release of IP and ensure timely availability of drug at the sites
  • Schedule and facilitate investigator meeting(s)
  • Develop site training materials for the study
  • Ensure accuracy of information for their study presented in study weekly dashboard(s)

Study Conduct And Close-out:

  • Monitor study enrolment and retention and act on deviations from plans
  • Identify barriers to enrolment and support recruitment and retention strategic solutions
  • Monitor and act upon study metrics – (review, trend-identification and analysis, with targeted follow up where appropriate)
  • Review Monitoring Visit Reports
  • Identify, resolve and escalate issues relating to study delivery, timelines and site budget to SETL
  • Ensure accuracy of information for their study presented in study weekly dashboard(s)
  • Manage all study close-out activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)
  • Coordinate and oversee data listing reviews
  • Ensure timely delivery of clinical documents for the Clinical Study Report (CSR) and appendices
  • For global, multi-country studies, SOL may oversee all Regional Operations Lead (ROL) study conduct activities in each region of study execution across startup, enrollment and maintenance, and close-out

Risk Assessment & Mitigation:

  • Proactively identify and communicate Clinical Operations risks and mitigations and align with cross-functional Study Execution Team on overall Risk Mitigation Plan
  • Drug or Investigational Product (IP):
  • Plan for timely delivery of IP to the sites
  • Provide Clinical Operations IP release package approval
  • Contribute to the study-level IP forecast                                                   
  • Perform study level IP inventory management and reconciliation

Lessons Learned:

  • Participate in, and contribute to “Lessons Learned” workshop and check-ins

Clinical Governance / Team Membership and Leadership:

  • Serve as core member of the SET
  • Provide guidance to ROL, Clinical Trial Specialist (CTS) and Sr. CTS assigned to studies, throughout study conduct


The Manager demonstrates advanced competence in Communication and Collaboration and Proactivity and Adaptability.  They demonstrate foundational competence in Leadership, Strategic Thinking, Analysis, and Problem Solving and Decision Making.  The People Development and Management competency is in development. For example:

  • Develops and delivers well organized and effective communication and presentations; can distill complex issues into simple key messages and provide appropriate context and level of detail
  • Takes ownership of, and accountability for, completing assigned tasks and perseveres through obstacles
  • Identifies stakeholders, gathers data and input, using multiple sources if applicable, to develop holistic understanding of, and assessment of a problem
  • Establishes team ethos of flexibility and adaptability; sets expectations for team members to be open to shifts in plans; handles tense, high pressure interpersonal and team situations in a calm and diplomatic manner
  • Understands and follows internal career development, performance measurement procedures and training protocols

The Manager is also expected to demonstrate advanced technical competence in Compliance and Quality and foundational skills in Study Management and Execution, Drug Development and Study Design and Product and Therapeutic Area Knowledge. For example:

  • Demonstrates a focus on overall compliance and quality, including ensuring that study practices are in compliance with SOPs and Good Clinical Practice (GCP) principles
  • Leverages deep understanding of clinical data flows and study related data deliverables to proactively identify potential data quality risks
  • Ability to build a relationship and collaborate with vendors to ensure clinical trials progress in accordance with agreed timelines and scope
  • Demonstrates a good understanding of project planning and timelines breaking down deliverables into milestones while balancing quality and timeliness
  • Familiar with basic financial management concepts including budgeting, PO, invoicing and forecasting
  • Can identify or explain study design; understands the differences between each type of clinical trial design
  • Demonstrates basic knowledge of drug(s) in use in study, the disease condition that the drugs(s) is/are treating, efficacy, safety concerns and development status


BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Clinical Operations has been defined and is available to employees of BioMarin


The Manager may have an opportunity to manage up to 2 direct reports, depending on business needs.


BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.

5+ years pharmaceutical industry experience; clinical research preferred.

Some travel may be required.


Internal: Clinical Operations team and Study Execution Team Members, Core Team personnel, GCP Compliance, other Clinical Operations personnel; Other BioMarin Worldwide Research and Development functional area personnel; BioMarin Senior Management

External:  CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies, clinical sites

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