Associate Director, Global Trial Leader - MAO (3 of 3)
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Global Trial Leader MAO. The position based in Titusville, NJ area, US, and Canada. Remote opportunities might be approved on a case-by-case basis in the countries listed. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities. Position
Summary:
Reporting to the MAO Global Program Leader (GPL), the Associate Director, Global Trial Leader (AD GTL) is accountable for end-to-end operational management of data generation activities. 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 AD 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 Clinical Trial Assistant (G-CTA) to ensure overall program delivery at the global, regional and country level. Principal
Responsibilities:
Single point of accountability for end-to-end operational management of the assigned programs 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 Tracks project progress against planned timelines. Monitors patient enrolment at global and or regional level. 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 requiredreports are generated and available for real time tracking of project status. 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. Ensures correct and timely reporting AEs/SAEs/PQCs, as appropriate. 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. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements. Identifies and proactively manages issues in a timely manner. Communicates and consults timely and regularly with the 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. The AD GTL contributes to or leads (cross-) functional process initiatives Mentors and coaches other GTLs or TLs. May be delegated to provide oversight or act as the Line Manager for GTLs, TLs and/or G-CTAs responsible for performance management, coaching and development planning.
Qualifications Education:
Bachelor's degree or equivalent required, preferably in Life Sciences. Required:
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. Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol specific procedures. Preferred:
Ability to work in a virtual and highly matrixed environment. 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. Other:
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. #GIFTS At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations North America-United States, North America-Canada Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105994376W
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Reporting to the MAO Global Program Leader (GPL), the Associate Director, Global Trial Leader (AD GTL) is accountable for end-to-end operational management of data generation activities. 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 AD 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 Clinical Trial Assistant (G-CTA) to ensure overall program delivery at the global, regional and country level. Principal
Responsibilities:
Single point of accountability for end-to-end operational management of the assigned programs 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 Tracks project progress against planned timelines. Monitors patient enrolment at global and or regional level. 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 requiredreports are generated and available for real time tracking of project status. 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. Ensures correct and timely reporting AEs/SAEs/PQCs, as appropriate. 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. Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements. Identifies and proactively manages issues in a timely manner. Communicates and consults timely and regularly with the 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. The AD GTL contributes to or leads (cross-) functional process initiatives Mentors and coaches other GTLs or TLs. May be delegated to provide oversight or act as the Line Manager for GTLs, TLs and/or G-CTAs responsible for performance management, coaching and development planning.
Qualifications Education:
Bachelor's degree or equivalent required, preferably in Life Sciences. Required:
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. Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol specific procedures. Preferred:
Ability to work in a virtual and highly matrixed environment. 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. Other:
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. #GIFTS At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations North America-United States, North America-Canada Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105994376W
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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