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EDUCATION AND EXPERIENCE REQUIREMENTS:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required!
• Skills-set commensurate with at least 6 years relevant clinical trial experience is preferred; however, other relevant experiences and skills may be considered
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills preferred.
• Excellent organisational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Perform activities in a timely and accurate manner.

• Provide administrative and logistical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.
• Supports the local study team in performing site feasibility and/or country feasibility.
• Maintains information in relevant systems.
• Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
• Support LTM and/or SM in collecting/preparing documents required for study startup/submission to IEC/IRB and/or HA.
• Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
• May assist LTM in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.
• Maintains and updates contact information in relevant systems to ensure appropriate safety updates distribution.
• Comply with all training requirements
• Ensure inspection readiness at all times.
• May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
• May be assigned as a coach and mentor to a less experienced CTA.
• Contributes to central business supports and process optimization with the support of other relevant functions in line with company’s requirements and business needs.
• Partners with Business Operations, CTA team, study teams and key stakeholders (e.g. Finance, Procurement etc.) to support routine clinical operations activities.