Johnson & Johnson Careers
Feasibility & Start-up Manager
Requisition ID: 1805679226W
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.
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
Janssen Biologics (7266)
Clinical Trial Coordination