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Global Trial Manager Managed Access
Beerse, Belgium; Netherlands; England, United Kingdom; Germany
Clinical Trial Coordination
Requisition ID: 1805641616W
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
We are looking for Global Trial Manager (GTM) Managed Access (MAc) within the Medical Affairs Operations department (MAO ) with the following responsibilities:
The MAO GTM MAc has the primary accountability at the project level within the GCDO organization. This includes all project activities starting from program planning through close-out of Managed Access initiatives according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements
Leads the MAc project team as the single point of accountability for end-to-end project management from program planning through start-up, intake, decision making, management and close-out of Managed Access initiatives on global and or regional level.
Is accountable for delivery of assigned projects within agreed budget. Ensures accurate project budget management and reconciliation of assigned projects for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
Tracks project progress against planned timelines. Monitors patient enrolment at global and or regional level, and ensures timely and accurate documentation and communication of project progress. Based on evolution of progress, initiates corrections to impacted operations.Provides regular status updates to the project team, project owners and Clinical Team / Medical Affairs members. Ensures required reports are generated and available for real time tracking of project status.
In coordination with the Study Responsible Scientist/Physician (SRS/SRP), and/or other project team members,the GTM provides adequate project-specific training to project teams and to the site staff/physicians.
Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPsand processes. Ensures quality oversight of assigned projects utilizing the available tools so that the project isin a constant state of inspection-readiness. Participates in preparation for, and conduct of, HA inspections andinternal Quality Assurance (QA) audits.
Identifies and proactively manages issues in a timely manner.
Communicates and consults timely and regularly with the AD GTM/CPL
Escalates issues to appropriate team members
Manages risks and builds proposal for Action Plan(s) with the project team to implement solutions on a project level.
The GTM MAc might be asked to take a role as SME for a MAc related expertise
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.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-United Kingdom-England
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination