Johnson & Johnson Careers

Feasibility & Start-up Manager

Leiden, Netherlands
Clinical Trial Coordination

Job Description

Requisition ID: 1805679226W

Global Clinical Operations (GCO) Janssen Biologics

Feasibility and Start-up Manager (FSM)

The purpose of the Feasibility and Start-up Manager (FSM) role is to support the feasibility and start-up for studies in scope of the Non-Core Country (NCC) model so that the activities under their remit are optimally carried out within the framework of the study Work Order (WO) and in compliance with Janssen SOPs and applicable Key Performance Indicators (KPIs). The FSM will do this by partnering closely with both in-house study teams and the CRO that has been contracted to perform these activities.
The FSM is responsible for the oversight of the CRO activities related to the feasibility studies and start-up phase of new studies that are performed within the GCO NCC model.
These NCC can be situated in either of the following regions: EMEA, APAC or LATAM. The FSM shall support the local CRO staff in their understanding of the NCC processes and communication lines and will drive predictability and success of study activities.

Primary responsibility will be to focus on the quality and commitments by reviewing the Key Performance Indicators for feasibility and start-up activities with the central study teams, the CRO Regulatory and Start-up Lead (RSUL), regional and local CRO teams; including but not limited to start-up metrics, operational metrics and quality metrics, as applicable, in conformance to all relevant laws, regulations, guidelines, policies and procedures.

As a member of the NCC Global Oversight Office, the FSM will liaise with the Non-Core Country Manager (NCCM) during the feasibility and start-up phase of the clinical trials and the Quality & Compliance Manager (Q&CM) within the NCC Global Oversight Office, to ensure that all activities are timely executed with the required quality.
The FSM needs to provide regional input and leadership towards the CRO teams, support GCO initiatives and show decision making capacity to escalate appropriately, and resolve where possible, any issues that may bring risk to the business. They should provide relevant information on the NCC to the central study teams, the CRO Global Lead and CRO oversight staff (Regional Operational Leads, ROLs) that sets the NCC up to better perform on trials.
The position reports to the Head of the Non-Core Country Global Oversight Office.
  • Contact person for questions related to feasibility and start-up processes in the Non-Core Countries as defined in the Operations Manual
  • Facilitate and support the request of the central team to receive a budget proposal from CRO and liaise between the central study team and the CRO until queries have been resolved and the budget is accepted.
  • Facilitate review and agreement by central study team and CRO RSUL of relevant actions and milestones for feasibility and/or start-up by being actively engaged in set up of Kick-Off meetings.
  • Ensure that regular telcons are held during feasibility and start-up between the central study team and the CRO RSUL to review progress and identify issues which may put a smooth and timely completion at risk.
  • Ensure that the Country Feasibility Report (CFR) provided by the CRO Regulatory and Start-Up Lead (RSUL) receives comments from the NCCM to the Global Trial Lead/Clinical Trial Manager (GTL/CTM) or Global Trial Manager (GTM), Regional Therapeutic Area Expert (RTAE), RSUL prior & during the local Review and Challenge meeting
  • Drive the efficient start-up of studies and follow-up on start-up activities and their timelines until the NCCM takes over when First Site Open (FSO) date is approaching, identify road blocks and escalate/resolve as appropriate to ensure timelines are met for Site Initiation Visit process
  • Provide support in keeping the written instructions and procedures for the CRO up-to-date e.g. Operations Manual, Task Ownership Matrix, etc.
  • Maintain oversight on the contracting process for initial investigator and ancillary contracts & amendments as supported by Contracts & Grants and flag if this process is not initiated and followed effectively and in a timely fashion.
  • Drive Key Performance Indicators related to feasibility and start-up with local team and CRO to support that that these are within agreed criteria and limits.
  • Support actions necessary to improve metrics per the metrics report and communicate with CRO staff until resolution
  • Support keeping the written instructions and procedures with CRO up-to-date e.g. Operations Manual, Task Ownership Matrix, etc.

  • A minimum of a Master’s degree or equivalent 
  • Proficiency in writing and speaking of English; multilingual skills is an advantage
  • A minimum of 6 years’ work experience in clinical trial execution is required 
  • Experience of successfully working a heavily matrixed organization.
  • High level of clinical trial experience (i.e. clinical operations) and knowledge of ICH-GCP in the pharmaceutical industry or CRO is required
  • Deep understanding of the Janssen R&D Clinical Operating Model including the roles and responsibilities of the various stakeholders preferred
  • Good understanding of clinical research including on-site monitoring and site management is required
  • Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard etc.) to analyze trial quality/performance and compliance and pick up trends and early warning signals is required
  • Strong ability to effectively communicate and understand issue escalation is required
  • Advanced communication skills allowing smooth and effective communication required
  • Previous experience in process development & process improvement is required
  • Experience in working in a virtual setting is required
  • Excellent interpersonal skills and ability to demonstrate leadership
  • Ability to liaise and negotiate in an excellent way with CRO staff and management
  • Experience with external vendor relationship management
  • Strong problem solving ability
  • Pro-active mindset and attitude
  • Able to identify opportunities for improvement and drive innovation in the region and in GCO organization as a whole
  • Ability to work in an international and diverse environment, with good cultural sensitivity
  • Strategic thinking
  • Big picture orientation with attention to details
  • Willingness to travel regionally/globally
  • Act and manage in line with J&J Leadership Imperatives: our Credo, connect, shape, lead and deliver

Primary Location
Netherlands-South Holland-Leiden
Janssen Biologics (7266)
Job Function
Clinical Trial Coordination
Requisition ID