Non-Core Country Manager (Global Clinical Operations)

Jobinhalt

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 clinical research including on-site monitoring and site management Experience of successfully working in 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 Deep understanding of the Janssen R&D Clinical Operating Model including the roles and responsibilities of the various partners preferred Ability to operate and proactively use various systems and databases (CTMS, Rave, VIPER Dashboard etc.) to analyse trial quality/performance and compliance and pick up trends and early warning signals Strong ability to effectively communicate and understand issue resolution is required Previous experience in process development & process improvement is required Experience working in a virtual setting is required Excellent interpersonal skills and ability to demonstrate leadership Demonstrate excellence in collaborating closely and negotiating with CRO staff, management and external vendors. A strong problem-solver with a pro-active approach and mentality Proactively seek 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 Critical thinking Big picture orientation with attention to details Act in line with J&J Leadership Imperatives and our Credo: Connect, Shape, Grow Other Proficiency in written and spoken English; multilingual skills is an advantage Willingness to travel regionally/globally Who We Are! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Primary Location United Kingdom-England-High Wycombe- Other Locations Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania, Europe/Middle East/Africa-Switzerland-Aargau-Baden, Europe/Middle East/Africa-Netherlands-South Holland-Leiden Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2206008802W