J&J Family of Companies Non-Core Country Manager in Leiden, Netherlands
The Non-Core Country Manager (NCCM) is responsible for the smooth start-up, maintentance and closeout of trials run in their allocated group of countries to ensure that the studies under their remit are run according to the agreed timelines, milestones, budgets and patient commitments. They will do this by partnering closely with both in-house study teams and the CRO that has been contracted to perform these activities.
The Non-Core Country Manager (NCCM) is responsible for the oversight of the CRO activities related to the studies that are performed within the GCO Non-Core Country (NCC) model.
These NCC can be situated in either of the following regions: EMEA, APAC or LATAM. The NCCM shall support the local CRO staff in their on-boarding and their delivering on study execution. He will drive predictability and success of study conduct.
Primary responsibility will be to focus on the quality and commitments by reviewing the Key Performance Indicators (KPI) with the local CRO teams; including but not limited to start-up metrics, operational metrics and quality metrics (KQPIs) in conformance to all relevant laws, regulations, guidelines, policies and procedures.
As a member of the NCC Global Oversight Office, the NCCM will liaise with the Feasibility and Start-up Manager (FSM) 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 NCCM needs to provide regional input and leadership towards the CRO local study 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, FSM and CRO oversight staff (Regional Operational Leads) 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 process related questions in the Non-Core Countries as defined in the Operations Manual
Support onboarding of new hires (e.g. JJEDs, IRIS, 1-supply), and approve access requests for GCO systems (if applicable)
Follow-up with the CRO Regional Operational Lead(s) that all new staff have access to supporting systems, are trained, and complete appropriately our core systems such as CTMS, vTMF, etc for all trials/countries.
Review Country Feasibility Report provided by CRO Regulatory and Start-Up Lead (RSUL) and provide comments to Global Trial Lead/ Clinical Trial Manager (GTL/CTM) or Global Trial Manager (GTM), Regional Therapeutic Area Expert (RTAE), RSUL and FSM prior & during the local Review and Challenge meeting
Drive the efficient start-up for the studies that are performed in their group of NCC. This will include: follow-up on start-up activities and become actively involved when the 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
Schedule regular update meetings (e.g. biweekly) with the Local Trial Manager to discuss study cycle progress and issue resolution
Follow-up proactively with the local study team that country/site patient commitments are met via recruitment strategy and action/contingency plans, if required, and support the resolution of issues that have been escalated
Drive Key Performance Indicators with local team to ensure that all quality indicators are green; including start-up metrics, operational metrics and quality metrics (KQPIs)
Support actions necessary to improve metrics per the metrics report, including drilling down to the site level and communicate with CRO staff until resolution
Maintain oversight on initial investigator contracts & amendments, and act as Escalation Point-of-Contact for both Contracts & Grants and CRO staff
Maintain oversight on initial ancillary contracts & amendments, if applicable, and act as Escalation Point-of-Contact for both Contracts & Grants and CRO staff
Maintain oversight on investigator/vendor payments in collaboration with Payment Coordinator
Maintain oversight on CRO activities regarding Clinical Study Report submission, 1-year post Investigator Financial Disclosure Form collection, and archiving of closed studies
Support keeping the written instructions and procedures with CRO up-to-date e.g. Operations Manual, Task Ownership Matrix, etc.
A minimum of a BS degree or 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
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
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.
Janssen Biologics (7266)
Clinical Trial Coordination