Clinical Trial Manager

Location:  London, United Kingdom Category: Clinical

Description

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 Development Sciences Operations (DSO) group is responsible for everything from research and discovery to post-market clinical development. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. 

BioMarin’s Clinical Operations group ensures proper planning, conduct, monitoring and data quality from study start-up to close-out. The group is responsible for fostering effective communication and collaboration between study sites and BioMarin.

 

SUMMARY DESCRIPTION

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.

                                                                                                                               

KEY RESPONSIBILITIES:

Responsibilities may include, but are not limited to:

 

Quality:

  • 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

 

Timelines:

  • 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

 

 

 

PEOPLE MANAGEMENT

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

 

EDUCATION AND EXPERIENCE

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.

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