・Reporting to the MAO Global Program Leader (GPL) or Associate Director Global Trial Leader (AD GTL), the GTL MAO is accountable for end-to-end operational management of data generation activities or managed access requests. This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.
・The GTL MAO serves as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the Global Program Leader (GPL), Global Operations Head (GOH), Global Trial Leader-Clinical Trial Assistant (GTM-CTA) to ensure overall program delivery at the global, regional and country level.
1. Single point of accountability for end-to-end operational management of the assigned programs
2. Is accountable for delivery of assigned programs within agreed budget. Ensures accurate program budget management and reconciliation of assigned projects for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
This includes forecasting and pro-active management of program specific budgets
3. Tracks project progress against planned timelines. Monitors patient enrolment at global and or regional level and ensures timely and accurate documentation and communication of project progress. Based on evolution of progress, initiates corrections to impacted operations.
Provides regular status updates to the project team, project owners and Clinical Team / Medical Affairs members. Ensures required reports are generated and available for real time tracking of project status.
4. Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes. Ensures quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness. Participates in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
5. Ensures correct and timely reporting AEs/SAEs/PQCs, as appropriate.
6. Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
7. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
8. Identifies and proactively manages issues in a timely manner.
- Communicates and consults timely and regularly with the AD GTL/GPL
- Escalates issues to appropriate team members
- Manages risks and builds proposal for Action Plan(s) with the project team to implement solutions on a project level.
9. The MAO GTL might contribute to or lead (cross-) functional process initiatives
Internal contacts: GOHs, GPLs, (AD) GTLs and G-CTAs, GCO Country Heads, Regional and Country Medical Affairs teams, Clinical Development Teams, GD functions, CMO, DMOA COEs FP, DPDS, Finance Department, Legal, Procurement, Regulatory, Quality Management & Training group; Study Management Teams, and other J&J enterprise sectors, as applicable.
External contacts: external service providers, clinical investigative sites and their research staff.
Education and Experience Requirements:
・Bachelor’s degree or equivalent required, preferably in Life Sciences.
・Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
・Specific therapeutic area experience may be required depending on the position.
・Project management skills and proficient communication skills are required.
・Ability to work in a virtual and highly matrixed environment.
・Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
・Strong IT skills in appropriate software and company systems.
・Excellent decision-making and strong financial management skills.
・Leadership skills and ability to influence without authority.
・Be an agent of change management.
・Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
・Willingness to travel with occasional overnight stay(s) according to business needs.
Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).