Project Specialist 2

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. 

We are searching for the best talent for a Project 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-up, maintaining key 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 completeness, inspection readiness, and compliance with applicable processes and timelines. .Manages Clinical Supply Chain for J&J Vision clinical studies by forecasting shipment needs, sourcing vendors, and coordinating budget, and sourcing and tracking of supplies for study start-up and ongoing execution. Coordinates duties of Clinical Operations Supplies Team (COST) to help ensure clinical supply needs are identified, 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 identify objectives, assign appropriate resources to deliverables, and track milestones of process improvement initiatives. Assist management 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 environmental objectives. Engages in Credo-based decision-making. 

Duties and Responsibilities: 

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

• Support clinical supply logistics for 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, and timely follow-up with study team partners and finance. 

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

• Assist with vendor management activities for Clinical Operations, including supporting vendor governance meetings, maintaining vendor-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, and maintain accurate project 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 ensure timely completion of assigned deliverables, issue escalation, and closure of open action items. 

• Support clinical study logistics, 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 departmental objectives. 

Qualifications: 

• Bachelor’s degree or equivalent experience required; preferred disciplines include business, life sciences, clinical research, finance, project management, or a related field. 

• Experience supporting clinical operations, clinical logistics, 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) and assisting with 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 accountability, management and 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 to maintain accurate records, 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 are identified. 

• Proficiency with 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.