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Manager, Study Management & Data Analytics

Location Tokyo, Japan
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. 

SUMMARY

The Study Manager provides study management support for trials within GMAF SM conducted within Japan, including project tracking (timelines and budgets), study maintenance and management, project planning, meeting facilitation, and vendor management. In addition the individual in this position within Japan will be responsible for managing the day to day activities associated with post marketing surveillance studies.

RESPONSIBILITIES

Vendor Management

  • Responsible for vendor selection, management and definition of performance metrics in collaboration with cross-functional business partners

  • Accountable for vendor performance, communication of expectations, and tracking of performance metrics at a study level

Study Oversight and Essential Documents

  • Develop and manage the budget, including tracking monthly spend against planned, and provide GMAF Study Management leadership with updates for assigned studies

  • Facilitate and manage monthly study team meetings, including review and approval of agendas and minutes and distribution of study updates within team

  • Collaborate with the Medical Directors and/or Medical Science Liaisons to support site and/or Ethics Committee questions about assigned study(ies)

  • Participate in the writing of study documents, including but not limited to protocols, informed consent form templates, regulatory reports, statistical analysis plans and study reports
  • Responsible for the final review of the site-level documentation and approval for initiation

  • Approve the study-level plans, including the monitoring plan

  • Accountable for product forecasting across all supply chain activities, including shipment and reconciliation

  • Define the country and site selection strategy and country-level feasibility assessment

  • Facilitate short and long term planning for assigned study

  • Accountable for the development and management of detailed timelines for assigned study(ies)

  • Responsible for trial master file (TMF) activities including establishing the TMF plan, managing the reconciliation process, and providing study-level content for filing into the TMF

Metrics, Data Collection, and Data Quality

  • Accountable for the development and utilization of metrics and management reporting tools for efficient study execution

  • Responsible for participating in the design of EDC data review tools, review of data quality review reports by assigned Study Team members, and resolution of identified issues

  • Participate in ongoing data review (DQRLs, line listings, etc.)

  • Responsible for implementation of periodic data collection and cleaning initiatives

  • Collaborate with pharmacovigilance on the reconciliation of events in the clinical and safety databases

Compliance and Risk Identification, Management, and Escalation

  • Lead or participate in the development and implementation of study-level corrective action plans

  • Anticipate, identify, and collaboratively address issues that may arise at a study level

  • Accountable for corrective and preventative actions resulting from site audits

  • Responsible for periodic review and disposition of protocol deviations

Post-Marketing Surveillance Studies

  • Develop materials for submission to regulators in collaboration with cross-functional partners

  • Ensure safety is reported according to BioMarin Pharmacovigilence processes and country specific regulations

  • Conduct advisory board meetings with investigators in collaboration with the medical director to provide updates on the PMS program

  • Audit study files to ensure they are ready for regulatory inspection

COMPETENCIES

A Manager demonstrates advanced competence in Communication, along with foundational skill in Leadership, Strategic Thinking and Planning, and Problem Solving and Decision Making. Skills include:

  • Distilling complex issues to simple terms, while driving information dissemination up and down the organization to influence appropriate outcomes

  • Ensuring that team roles and responsibilities are clearly defined, understood, and fulfilled

  • Contributing to the development of a motivating team/work environment by upholding positive morale and encouraging high performance

  • Demonstrating an ability to recognize, understand, articulate and respond promptly to issues that arise, escalating as appropriate

  • Excellent written and verbal English communication skills

The Manager is also expected to demonstrate advanced technical competence in Compliance and Clinical Trial and Project Management. This includes:

  • Demonstrating robust knowledge of GCP and GVP guidelines and their impact on each stage of the trial (start-up through close-out)

  • Ability to identify and mitigate compliance risks across a clinical trial

  • Demonstrating command of site management and co-monitoring

  • Demonstrating an ability to lead efforts in identifying and selecting vendors for assigned clinical trials 

  • Computer Skills - Microsoft Office 365 suite (Word, Excel, PowerPoint, SharePoint, Project)

EDUCATION & EXPERIENCE

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

  • 6 years of pharmaceutical industry experience

  • 4 years of experience in clinical research, including:

    • Experience operationalizing PMS studies, including thorough knowledge of regulations governing their management

    • Managing PMS studies for global companies in a matrix environment

    • Some line management experience (0-2 years) is preferred

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions

CONTACTS

Internal: Global Medical Affairs Study Management & Data Analytics, Clinical Operations, Market Planning, Commercial / Market Access, Regulatory Affairs, Regulatory Patient Engagement, MD/MSL, Medical Information, Legal / Compliance, Medical Communications, Pharmacovigilance, DSQ, Medical Affairs Operations

External:  Clinical Study Sites, regulators, vendors and suppliers



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.

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Tokyo

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