Johnson & Johnson Careers

Global Trial Manager Managed Access

Beerse, Antwerp
Clinical Trial Coordination


Job Description

Requisition ID: 1805641616W

We are looking for Global Trial Manager (GTM) for the Managed Access team within the Medical Affairs Operations department (MAO), which is part of the Global Clinical Development Organization (GCDO). The successful candidate will be accountable for operational planning, management and execution of Managed Access Programs, including Post-Approval Access, Post-Trial Access and Pre-Approval Access initiatives such as Compassionate Use and Named Patient Programs. These programs are key to ensure access is granted to investigational products to treat patients with serious/life threatening diseases or conditions, where alternative treatments do not exist or have been exhausted. In this role, you will lead the operational activities of these programs across multiple Therapeutic Areas in alignment with local regulations, and in collaboration with key stakeholders from R&D and Medical Affairs (Commercial).
 
 
Key Responsibilities for the GTM Managed Access:
  • Leads the Managed Access program team as the primary point of accountability for end-to-end program management from program planning through start-up, intake, decision making, management and close-out of Managed Access initiatives on global and/or regional level.
     
  • Tracks program progress against planned timelines. Monitors patient enrolment at global and or regional level, and ensures timely and accurate documentation and communication of program progress. Based on evolution of progress, initiates corrections to impacted operations.
     
  • Accountable for delivery of assigned program within agreed budget. Ensures accurate program budget management.  Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
     
  • Coordinate stock management of investigational product for the programs in collaboration with commercial and clinical supply units
     
  • Partners with other functions including Medical Affairs (Global/Regional/Local), Patient Support, Regulatory Affairs, R&D Operations, external service providers and other J&J enterprise sectors, as applicable.
 
  • Provides program-specific training to local teams and to site staff/physicians (in coordination with the Study Responsible Scientist/Physician (SRS/SRP), and/or other program team members).
 
  • Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes.  Ensures quality oversight of assigned programs utilizing the available tools so that the programs is in a constant state of inspection-readiness. Participates in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
 
  • Identifies and proactively manages issues in a timely manner; Escalates issues to appropriate team members; Manages risks and builds proposal for Action Plan(s) with the program team to implement solutions on a project level.
 
  • Takes a role as subject matter expert (SME) for a Managed Access-related expertise
 
  • Leads or supports Managed Access strategic projects or continuous improvement initiatives, as assigned.
 
This role will report to one of the Associate Director GTMs, who are each responsible for a cluster of Therapeutic Areas.

Qualifications
Qualifications
  • Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • 5 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
  • Clinical operations knowledge, project management and proficient communication skills are required.  Computer literacy is also required.
  • Effective project team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage global or regional teams in a virtual environment are needed.
  • Excellent decision-making and strong financial management skills.
 

Primary Location
Belgium-Antwerp-Beerse
Other Locations
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-United Kingdom-England
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Clinical Trial Coordination
Requisition ID
1805641616W