J&J Family of Companies Associate Director, Global Trial Leader in Titusville, New Jersey
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Global Trial Leader. This position can be located in Titusville, NJ; Raritan, NJ; Horsham, PA; or Spring House, PA. Remote locations within the East Coast of the United States may be considered.
Reporting to the MAO GCDO Program Leader (GPL), the Associate Director, GCDO 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 GCDO Program Leader (GPL), GCDO Operations Head (GOH), Global Clinical Trial Assistant (G-CTA) to ensure overall program delivery at the global, regional and country level.
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 required reports 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 staying in sync 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 TMs.
May be delegated to provide oversight or act as the Line Manager for GTLs, TMs and/or G-CTAs responsible for performance management, coaching and development planning.
Internal contacts: GOHs, GPLs, GTLs and G-CTAs, GCO Country Heads, Regional and Country Medical Affairs teams, Clinical Development Teams, GCDO 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.
A minimum of a Bachelor’s degree or equivalent experience is required, preferably in Life Sciences.
Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO is required.
Experience in the Oncology therapeutic area is preferred
Ability to work at global, regional, or local levels with multiple business stakeholders is preferred
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 is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, North America-United States-Pennsylvania-Horsham
Janssen Research & Development, LLC (6084)