Johnson & Johnson Careers

Process and Sourcing Lead

Beerse, Belgium; Netherlands; Switzerland
Clinical Data Management


Job Description

Requisition ID: 1805685830W

 
The Process and Sourcing Lead is accountable for supporting and maintaining a sourcing framework within Data Management and Clinical Development Standards.  Framework for sourcing should consider vendor performance, customer performance, quality and cost.
 
Under supervision of Head, Process and Sourcing, the incumbent drives the vendor portfolio allocation process.
 
Process and Sourcing Lead is accountable for supporting the tracking of any CAPAs related to Data Management and or Clinical Development Standards as well as providing coordination support for HA / Inspection prep, as required and assigned by Head Process and Sourcing. 
 
Process and Sourcing Lead will develop operational / functional relationships with vendor in collaboration with Data Management Leads and Data Managers in each therapeutic area, providing insight and input on an effective operating model.
 
Process and Sourcing Lead will help provide project management support for initiatives in Data Management, as required.
 
This position provides input into the development of departmental policies, procedures, training and standards
 
Implement and Support Sourcing Strategy for Data Management:
 
  1. Support the implementation of a future sourcing strategy for Data Management
  2. Continue to enhance and executes the DM sourcing strategy, build stronger vendor partnerships, perform internal voice of customer to ensure that Janssen portfolio delivery is streamlined.
  3. Identifies process optimization and innovation within Data Management sourcing and processes.  
  4. Makes recommendations around process/policy deviations to adhere or adjust to local or project requirements.
  5. Supports building cost comparisons models for activities across vendors and proposes solutions to continue driving cost effectiveness across the DM organization.
  6. Partners with Data Management Leads, procurement and external alliances to build a robust framework of working in a collaborative manner with clear R&Rs.
  7. Through an internal and external voice of customer and additional data gathered through metrics, identify root cause issues, working with internal Janssen and vendors on a concrete plans to address issues
  8. Take a leadership role in establishing best practices for vendor effectiveness across all vendors partnering with Data Management and Clinical Development Standards
 
 
Supporting Process / SME Network and Data Management related CAPA management
 
Provides strategic and project management support to the Data Mangaement and Standards SME network and the CAPA management process, ensuring effectiveness and transparency in communication.
 
  1. Drive effectiveness of the SME network by providing project management support to drive efficiencies in Data Management. 
  2. Assist in coordinating HA inspections / Audit readiness
  3. Coordinates with functional Data Management Leads and other colleagues to ensure alignment of departmental roles and responsibilities.
 
Responsible to provide input into the development of departmental policies, procedures, training and standards. 

  1. Policy and standards development and compliance as it relates to the sourcing, vendor partnerships and SME networks.  
  2. Participates in and/or lead global cross-functional and cross-company initiatives, as applicable.
  3. Own one or more department procedures, ensuring the processes are up to date and efficient.
Lead process improvement projects, as needed, to continue building best in class Data Management organization
 
This position reports to Head Sourcing and Process in Data Management.  There are regular interactions with the Sourcing and Process Head, DM&CDS Head, Data Management Leads and senior leadership to identify and share input for strategies and approaches.  Work is received in broad terms and this position is provided independence for execution
Functional Contacts within IDAR include but are not limited to:  Sourcing and Process Head, Data Mangaement Head, Data Management TA Heads and all other peers in IDAR business office, DMLs, Data Managers, Regulatory, etc..
Functional Contacts Inside the Company (as collaborator and/or peer) include but not limited to: Employees from other departments within Global Clinical Development Operations, eBIS, Quantitative Sciences, BioResearch Quality & Compliance, Project Management Organization, Regulatory Affairs and Operations, Human Resources, Finance, Information Technologies, Janssen R&D Procurement and External Alliances. Cross-sector counterparts in Consumer Devices and Vision Care as necessary.
Therapeutic Area Contacts Inside the Company (as collaborator, Sourcing and Process advisor) indirect contact.
Contacts Outside the Company (as collaborator or advisor):  Act as J&J representative in Industry counterparts and working groups

Qualifications
BS/MS plus 5-7 years of experience in a vendor management and / or Clinical Data Management function.  Excellent communication and partnership skills.  Extensive understanding of vendor management / establishing alliance partnerships, general knowledge of clinical operations and data management practices and systems is needed.  The Sourcing and Process Lead should have a working knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts. 
In-depth knowledge of project management, team leadership and people development practices.  
 
This position requires knowledge related to building effective partnerships internally and externally.  This position requires knowledge of cross-functional working environment and industry trends that have an effect on departmental resources.  This position also requires knowledge of sourcing strategies, resource management, and organizational impact.

Primary Location
Belgium-Antwerp-Beerse
Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Clinical Data Management
Requisition ID
1805685830W