Project Specialist 2

About Vision

Fueled by innovation at the intersection of biology and technologyweredeveloping the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding onthe possibilities of vision treatments Ready to join a teamthatsreimagining how vision is improved Our Vision team solves the toughest health challenges. Help combinecutting-edgeinsights science technology and people to encourage eye care professionals and patients to proactively protect correct and enhance healthy sight for life. Our products and services address these needs from the pediatric toagingeye in a patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at internal pre-identified candidate for consideration has beenidentified. However all applications will be considered.

We are searching for the best talent foraProject Specialist 2.

The Project Specialist 2 supports J&J Vision as part of the Clinical Logistics group within Clinical Operations with responsibility for coordinating activities related to clinical study supplies Clinical Operations finance and vendor management. This role supports operational execution by tracking deliverables coordinating cross-functional follow-upmaintainingkey documentation and trackers and helping ensure study teams have the supplies financial support and vendor coordination needed to execute clinical studies effectively.

Serves as a Trial Master File (TMF) resource for Clinical Logistics-related documentation including CSU-related documents clinical supply records vendor documentation and finance-related records as applicable. Supports TMF completenessinspectionreadiness and compliance with applicable processes and timelines..ManagesClinical Supply Chain for J&J Vision clinical studies by forecasting shipment needs sourcing vendors and coordinating budget and sourcing andtracking ofsupplies for study start-up and ongoing execution. Coordinates duties ofClinicalOperations Supplies Team (COST) to help ensure clinical supply needs areidentified tracked and supported across assigned studies.

• Drives the implementation of new / novel processes and systems for continuous improvement in Clinical Logistics. Responsibilities may include using tools to identifyobjectives assignappropriate resourcesto deliverables and track milestones of process improvement initiatives.Assistmanagement in the review of department procedures and recommend policy changes in response to both internal and external requests.

• The position requires strong organizational skills attention to detail effective communication and the ability to follow up on time-sensitive deliverables to help ensure clinical studies are supported within established timelines budgets and applicable business processes.

• Adheres to environmental policy procedures and supports department environmentalobjectives. Engages in Credo-based decision-making.

Duties and Responsibilities:

• Coordinate and support Clinical Logistics project activities across J&JVision includingclinical supply coordination Clinical Operations finance support vendor management activities study-related planning tracking documentation and stakeholder follow-up.

• Support clinical supplylogisticsfor assigned studies including coordination of study supply needs tracking supply availability and distribution status supporting readiness for site start-up and ongoing study execution and following up with internal partners to resolve supply-related issues.

• Support JJV study budget activities including budget tracking purchase order monitoring invoice coordination accrual support budget-versus-actual reviews andtimelyfollow-up with study team partners and finance.

• Coordinate the JJV study budget e-payment process and provide proactive follow-up to help ensuretimelypayment processing issue resolution and alignment with Clinical Operations finance processes Finance Procurement vendors and study teams.

• Assistwith vendor management activities for Clinical Operations including supporting vendor governance meetingsmaintainingvendor-related information tracking action items and coordinating with internal stakeholders to support business and compliance requirements.

• Support review and coordination of study-related agreements statements of work purchase orders invoices and other operational documents as needed.

• Partner with cross-functional teams to support process improvement initiatives operational efficiency projects and harmonization of Clinical Operations processes across JJSV and JJVC.

• Prepare organize andmaintainaccurateproject documentation trackers meeting minutes action logs budget templates and status updates to support transparent communication and decision-making.

• Follow up with internal and external stakeholders to ensuretimelycompletion of assigned deliverables issue escalation and closure of open action items.

• Support clinical studylogistics supply readiness Clinical Operations finance activities vendor coordination budget planning and operational readiness activities as assigned by management.

• Adhere to applicable company policies procedures environmental requirements and departmentalobjectives.

Qualifications:

• Bachelors degree or equivalent experience; preferred disciplines include business life sciences clinical research finance project management or a related field.

• Experience supporting clinical operations clinicallogistics clinical supplies project coordination Clinical Operations finance processes budget management vendor oversight or finance-related business processes preferred.

• Experience in a medical device pharmaceutical clinical research healthcare or similarly regulated environment preferred.

• Ability to manage competing priorities track deliverables and follow through effectively with cross-functional stakeholders.

Experience in:

• Medical device or pharmaceutical industry.

• Clinical Trial Management Systems (CTMS) Electronic Data Capture (EDC) tools and budget tracking.

• Managing study documentation (TMF/eTMF) andassistingwith site management vendor management and data management.

• FDA regulations HIPAA and safety reporting protocols.

• Clinical processes and clinical trial regulations per ISO14155 and/or ICH-GCP.

• Interaction with teams that support FDA and/or other health authorities.

• Managing a team and providing oversight and training.

• Test article accountabilitymanagementand reconciliation

• Strong written and verbal communication skills with the ability to interact professionally with internal business partners Finance Procurement vendors and study team members.

• Strong organizational skills and attention to detail with the ability tomaintainaccuraterecords trackers and action-item follow-up.

• Working knowledge of clinical operations clinical supply chain clinical logistics study budget management vendor coordination purchase orders invoices and payment processes preferred.

• Ability to work independently within established guidelines and escalate issues appropriately when risks delays or process gaps areidentified.

• Proficiencywith Microsoft Office applications including Word Excel PowerPoint Outlook and Teams; experience with SharePoint or similar collaboration tools preferred.

• Ability to support continuous improvement efforts and contribute to efficient compliant and transparent Clinical Operations processes.