Johnson & Johnson Careers
Global Trial Manager-Associate Director
Requisition ID: 1805663309W
The position of Global Trial Manager Associate Director will be part of Medical Affairs Operations (MAO) organization reporting to the MAO Clinical Program Leader (CPL) and is accountable for leading with success the execution of data generation activities for project(s) assigned by the CPL, Functional Manager, or Clinical Operations Head (COH).
He/she serves as the single point of end-to-end accountability for assigned project(s); leading the Study Management Team (SMT) for global, regional or complex local studies, interfacing with the Clinical Teams, GCDO functions, R&D Operations (RDO), stakeholders from regional/local Medical Affairs or other internal trial sponsors, external service providers e.g. contract research organization (CRO) and/or other J&J enterprise sectors, as applicable.
He/She has the primary accountability at the trial level within the GCDO organization. This includes all project activities starting from protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.
The selected person will provide operational leadership to the execution plan and defines risk mitigation strategies and ensures implementation thereof. He/She maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Scientist/Physician. This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
The position can be performed by any location within EMEA. No relocation required.
- Leads the SMT as the single point of accountability for end-to-end project management including trial set-up, execution, close-out, analysis and reporting.
- For projects executed in-house, the GTM will oversee and support local Trial Managers and teams in the daily operational activities in line with country specific regulations and internal processes, if required.
- For projects outsourced to a CRO, the GTM will oversee and monitor the CRO’s performance on all contracted services
- Is accountable for delivery of assigned trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials 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.
- Tracks project progress against planned timelines. Monitors patient recruitment rate to ensure that target
- enrollment will be met across the allocated regions/countries.
- Provides regular status updates to SMT, project owners and Clinical Team members. Ensures required reports are generated and available for real time tracking of project status.
- In coordination with the CPL/COH, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the GTM provides adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.
- 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.
- Identifies and proactively manages issues in a timely manner.
- Communicates regularly with the CPL/COH.
- Escalates issues and manages risks related to resources, timelines and budgets.
- Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.
- Mentors and coaches other GTMs or TMs.
- May be delegated to provide oversight or line manage or act as a Functional Manager for GTMs,TMs and/or GTM-CTAs, especially on complex or focused projects/programs within the CPL’s portfolio/program.
- Maybe delegated to act as a back-up for the CPL, if needed
- Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- 8 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
- Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage global or regional study teams in a virtual environment are needed.
- Previous line management experience is a plus, but not required.
- Excellent decision-making and strong financial management skills are essential for this position
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom-England, Europe/Middle East/Africa-Netherlands
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination