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29 days old

Global Trial Leader

Kelly Services
Raritan, NJ 08869
Global Trial Leader MAO- Position Summary: 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. Principal Responsibilities: 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. Version 2.0 dated 15APR2020 FINAL Job ID: 10001475: Job Code: R D, JOB SUBFUNCTION Central Trial Coordination PG30 , Global Trial Leader MAO Page 2 of 2 For Internal Use Only 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 Principal Relationships: 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 ap


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-13 Expires: 2022-08-13

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Global Trial Leader

Kelly Services
Raritan, NJ 08869

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