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**Non-Core Country Manager (NCCM) (Global Clinical Operations)**:
Who is Janssen? We're more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. Our mission is to transform individual lives and fundamentally change the way diseases are handled, interpreted, and prevented. We believe challenging something is the best way to change it. So every day, in more than 150 countries, we bring innovative science and the most creative minds in the industry together to think differently about diseases.
We have an excellent opportunity for a **Non-Core Country Manager (NCCM) located preferably in the EMEA Global Clinical Operations (GCO) region,** to oversee CRO activities related to studies performed within the GCO Non-Core Country (NCC) model. You will partner closely with both in-house study teams and the CRO that has been contracted to perform these activities.
The NCCM manages the smooth start-up, maintenance and closeout of trials in their allocated group of countries, enabling studies to run to agreed timelines, milestones and patient commitments. Conformance to relevant laws, regulations, guidelines, policies and procedure is achieved by reviewing Key Performance Indicators (KPI) with the local CRO teams. The position reports to the Director Non-Core Country Model Global Oversight Office.
As NCCM, you will collaborate closely with the Feasibility and Start-up team and the Compliance team within the NCC Global Oversight Office. You will 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. You should provide relevant information on the NCC to the central study teams, NCC colleagues and CRO oversight staff (Regional Operational Leads) that sets the NCC up to improve performance.
**Principal Responsibilities**:
- Drive the efficient start-up for the studies to 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
- 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
- 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 intensified issues
- Drive Key Performance Indicators with local team to ensure that all quality indicators are green; including start-up metrics, operational metrics and quality metrics
- Support actions vital to improve metrics 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 Contract & Compliance Services (CCS) and CRO staff
- Oversee investigator/vendor payments in collaboration with Payment Coordinator
- Oversee 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
**Principal Relationships**:
Contacts inside the company may include: Global Program Lead (GPLs), Global Trial Lead (GTLs), Clinical Trial Managers (CTMs), GCO Country Managers/Heads, Clinical Research Manager (CRM)/Functional Manager (FM), Clinical Team members, Medical Affairs (MAF) and Commercial teams (as required), Local Operation Company staff in non-core countries, support functions like, Safety Unit (SU), Contracts & Compliance Services (CCS), Legal counsel, Health Care Compliance (HCC), Finance, Information Technology (IT), etc.
Contacts outside the company may include: CRO staff: Regional Operational Lead (ROL), Local Trial Manager (LTM), Site Manager (SM), Clinical Trial Assistant (CTA), Site Activation Manager (SAM), Regulatory Maintenance Lead (RML); Investigational Sites, Key Opinion Leaders (KOLs), Academic Centers, local vendors, etc.
**Qualifications**
**Education and Experience Requirements**:
- A minimum of a BS degree or Master’s degree or equivalent
- Extensive work experience in clinical trial execution with a good understanding of cl
