Johnson & Johnson Careers

Business Support Analyst - SSU

Beerse, Belgium
Clinical Data Management

Job Description

Requisition ID: 1905775498W

Business Support Analyst - SSU 
Location: Flexible - European regional offices.


Responsibilities include serving as liaison between the business community and TMF CoE/EBIS partners to provide guidance on Study Start-Up process, business use of V-TMF Study Start Up (SSU) and CLIX Document Exchange (DocX) capabilities and leadership in development of business solutions to meet user needs. Supports process design and documentation as needed.  Reviews metrics and trends and communicates these findings to Management to proactively identify gaps in process and efficiencies.  Collaborates with other members of the team and the business in the translation of business needs into specifications for the solution.  Serves as point of contact for initial process discussions when new departments or organizations are being brought into the TMF system using SSU an DocX.


1. Understands Clinical Trial processes in order to identify opportunities to automate or streamline EBIS business processes and system functionality.
2. Resolves most problems directly within the area of responsibility, or by escalating the problem to the correct resource.
3. Follows established procedures to test new software or enhancements to existing software.
4. Participates in and Supports Audits/Inspections as needed.
5. Responsible for supporting SSU and DocX business user questions within the applicable solution and in collaboration with the technical support team.
6. Supports study team in resolution of site staff end user questions and adoption of system.
7. Responds to user problems, explains new technologies and presents deliverables.
8. Forms productive relationships with internal business partners by listening, clarifying and responding effectively.
9. Coordinates and leads discussions as point of contact for the on-boarding of new departments or organizations
10. Coordinates alignment in use of SSU and DocX system functionality between J&J sectors
11. Works independently or as a part of a team under general supervision. 
12. Must understand and be compliant with TMF COE SOPs, WIs and guidelines.


A BA/BS degree is required. A degree in health, science or information technology is preferred. Pharmaceutical industry experience directly involved with study start up processes and/or the collection and creation of a variety of TMF content; knowledge of the complete clinical trial conduct process. Good understanding of the drug development process including ICH/GCP and local regulatory requirements. Experience in database administration and/or the familiarity of electronic trial master files is preferred.

Minimum of five years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

Ability to provide general business oriented assistance. Superior communication, problem solving and prioritization skills are also required. The individual must be self-motivated with a track record of demonstrated aptitude in working in a team-driven environment. Must have the ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment.

Primary Location
Janssen Pharmaceutica N.V. (7555)
Job Function
Clinical Data Management
Requisition ID