Barbara Bruyndonckx

Responsibilities:

• To act as the Managed Access operations expert and to be accountable for business development of Access initiatives in assigned Therapeutic Area's
• To act as the Point of Contact within Global Development for the Compound Development Team / Global Medical Affairs Leader and to support in establishing a well-coordinated approach to manage Managed Access on portfolio level
• To manage relationships with regional and local Medical Affairs to advise on regional and local preapproval and managed access needs in the Therapeutic Area’s
• To serve as the primary point of contact to pick-up and manage ad-hoc requests, to oversee
  implementation and to keep oversight of managed access activities in the Therapeutic Area’s
• To identify and proactively manage issues in a timely manner and to build proposal for action plan and to translate ad-hoc solutions into lessons learned for team members and other functions
• To oversee the start-up and execution and close out of assigned programs and to lead a team of Global Trial Leaders, Trial Managers, Clinical Trial Assistants
• To act as line manager for Global Trial Leaders, Trial Managers, Clinical Trial Assistants, responsible for performance management, coaching and development planning

Performing services as a Global Trial Leader on behalf of Johnson & Johnson Innovative Medicine - Medical Affairs Operations - Managed Access

performing services as a Senior Local Trial Manager on behalf of Janssen Pharmaceutica NV Global Clinical Operations Belgium & the Netherlands.

Responsibilities:

• To manage the local execution of study activities, leading the local trial team of on-site monitors (Site Managers) and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team (for Inflammatory Bowel Disease Studies in Adult patients & Pediatric patients)
• To serve as the primary point of contact at a country level and report study progress to key stakeholders
• To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team
• To provide expert input and independently create key study plans
• To develop and implement the use of local study tools (e.g. recruitment plans, risk management plans)
• To track the reporting of SAEs
• To maintain and update trial management systems (with the support of a Clinical Trial Assistant)
• To plan and participate in investigator meetings
• To review visit reports for completeness and adherence to the protocol and to identify site issues and trends
• To collaborate with other study team members as well as investigators and other site staff to build strong working relationships
• To be involved in innovative projects e.g. implementation of electronic consent process in a pediatric trial

Responsibilities:

• Select and activate EU sites, establish and maintain an excellent relationship with site investigators and research teams
• Create and update EU activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines, and objectives
• Supervision of EU CRA monitoring activities
• Ensure study quality/GCP compliance to deliver a rigorous patient data
• Manage new trials and provide oversight to all
  vendors and internal study team, ensuring timely delivery of milestones and within budget
• Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs
• Liaise with manufacturing, central lab and other study project stakeholders as needed
• Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g. Patient Informed Consent Forms, Monitoring Plans, Project Plans)
• Develop project plans and maintain study timelines and study budget
• Responsible for ensuring vendors deliver according to scope of work and review / approve vendor invoices

Responsibilities:

• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensure key stakeholders are kept informed of study progress
• Supports country-level operational planning and site selection within region
• Provides regional level input into the Country Operational Plan and partner with the Feasibility Manager and Global Clinical Trial Manager to ensure regional delivery of the Global Study Operational Plan
• Support and contribute to Clinical Study Teams, agenda driven presence at Clinical Study Team meetings (global and study-level as required)
• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their region
• Coordinates cross-functional review of issues escalated directly from sites or via the CRO CRA and facilitates resolution
• Oversight and monitoring of applicable vendor activities e.g. laboratories, IVRS, Imaging and equipment provisioning
• Contribute to development of study-specific materials e.g. monitoring plan, study-specific training documents
• Contribute to, deliver and/or lead CRO CRA, Investigator and Study Coordinator training
• Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g. vendor management
• Execute regulatory agency inspection readiness activities within region
• Contribute to study-level investigational product management
• Monitor the execution of the clinical study against timelines, deliverables, and budget, across multiple countries:
  - Translate global start up requirements into regional/local targets
  - Monitor regional enrolment and retention and act on deviations from plan
  - Monitor and address any issues with data flow metrics
  - Monitor and review country/regional trends
  - Review Monitoring Visit Reports
• Oversight of local study team deliverables within region
• Participation in cross-functional task forces / process improvement groups
• Accountability for key activities associated with operational execution of studies in support of local/regional evidence generation, including internal/external stakeholder engagement activities and the support of local vendor outsourcing where required

For different phase 0, 1, 2 and 3 oncology / hematology studies (therapeutics and supportive care) in Belgium, Luxemburg, Netherlands, Middle East, Africa and Turkey