At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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Engineer, Clinical Trial Management Solutions

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for an Engineer, Clinical Trial Management Solutions to provide support in the planning, administration and oversight of clinical systems and related processes administered by Enabling Analytics System Excellence (EASE) within Clinical Trial Management Solutions (Clin Trial Mgmt Sol). This position may be located within commutable distance of High Wycombe, United Kingdom; Beerse, Belgium; Breda, Netherlands; or Warsaw, Poland.

You will be responsible for:

• The Engineer, Clinical Trial Management Solutions provides support for capabilities related to clinical trial document management/TMF, study management and oversight.
• Under general supervision, this role implements plans that innovate product development, meet organization standards, and follow digital strategy. This role is a liaison between the business community and key partners and stakeholders. The Engineer Clin Trial Mgmt Sol supports the enhancement and optimization of capabilities and processes, fostering collaboration to drive strategy, efficiency and quality across J& J systems and development initiatives.

Are you ready to join our team? Then please read further!

Qualifications / Requirements:

• Serves as support to the solution owner in coordinating the delivery of tools to clinical trial teams.
• Collaborates with clinical trial teams and vendors to ensure solutions meet trial needs and timelines, providing feedback and facilitating communication between parties.
• Work with study teams and partners on the study build, maintenance and use of capabilities during the lifecycle of a study.
• Provide end user support and expertise via support ticket intake, mailbox inquiries or other mechanisms.
• Contribute to system release management including UAT testing and system improvements, and development/maintenance of system integrations.
• Create / update training materials and reference documentation to support end users, and present to user community groups to drive usage and compliant use of systems.
• Prepares reports and updates on the usage and effectiveness of tools, providing insights and metrics for leadership.
• Support continuous improvement by engaging in discussions with business stakeholders, using data (e.g. SQL queries, report generation) to identify areas of opportunity, and implementation of new technologies (e.g. robotic process automation, bots, AI, and other processes) to meet business needs.
• Contribute to or lead projects of smaller to moderate scope and participate in cross functional projects.
• Collaborate with Subject Matter Experts, Process Owners, and Functional Management to ensure alignment with study/project timelines, organizational SOPs, and regulatory requirements.
• Support audit / inspection activities, including CAPA management.
• May Sponsor external resources under the supervision of a more senior team member.
• Represent on organizational initiatives as appropriate.

Education and Experience Requirements:

• A minimum of a bachelor’s degree or equivalent is required, preferably in Health, Science, Information Technology or another relevant field.
• A minimum of 3 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required!
• Experience working with IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required. Experience with direct support of IT systems and related processes that support clinical development is preferred.
• Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
• Excellent analytical, problem solving, communication and presentation skills.

Preferred

• Trial Master File experience with Veeva Vault preferred.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-007679

Belgium, Netherlands & Poland - Requisition Number: R-009703

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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