Celcuity

QA Engineer

• Monitor the company’s dedicated inbox for Quality Incidents and potential issues and initiate processing in a timely manner.
• Maintain documentation that establishes tracking and oversight of Quality Incidents through resolution and/or closure.
• Maintain tracking information for the availability of inspection-ready documentation associated with staff qualification and training.
• Coordinate, oversee, and maintain documentation of GxP vendor risk assessment and qualification activities.
• Perform background checks on internal staff, vendors, and Celcuity research partners for FDA debarment, enforcement actions, and international regulatory restrictions or sanctions.
• Review documents, as assigned, for internal consistency and congruency with specified external standards as a compliance and data integrity check.
• Coordinate the development and revision of procedural documents governing QA activities, contributing to continual process improvement.
• Support the development of summary metrics for trending and for presentation to upper management and departmental heads.
• Participate in and support other areas of QA responsibilities as assigned and identified in the position summary.
• Conduct and/or oversee reviews of analytical protocols and reports, batch records, CMC submission documents, etc to assure that such records reflect requisite integrity and comply to applicable requirements.
• Other duties as assigned.

Quality Assurance Coordinator

Director

• Responsible for timelines and quality of CDM deliverables for the assigned studies
• Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
• Ensures Data Management Plans are followed through the course of the studies
• Provides feedback and task assignment to meet department and company objectives
• Supports budget and resource planning across assigned projects as required
• Participates in CRO/vendor selection process for outsourced activities
• Directs activities of direct reports as applicable
• Participates in department or cross-functional initiatives as appropriate
• Represents CDM in study team meetings
• Manages or establishes CDM timelines to synchronize deliverables with the overall study timelines
• Proven ability to perform detailed hands-on work as well as high-level strategic task
• Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions)
• Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices)
• Monitors the progress of all CDM activities for the project to ensure project timelines are met
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial
• Performs duties as assigned by CDM management/Head of Department.

Associate Director/Director, Clinical Data Management

Manager

• Responsible for timelines and quality of CDM deliverables for the assigned studies
• Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
• Provides feedback and task assignment to meet department and company objectives
• Supports budget and resource planning across assigned projects as required
• Participates in CRO/vendor selection process for outsourced activities
• Directs activities of direct reports as applicable
• Represents CDM in study team meetings
• Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines
• Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions)
• Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices)
• Monitors the progress of all CDM activities for the project to ensure project timelines are met
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, and able to work independently towards the assigned goal
• Performs duties as assigned by CDM management/Head of Department.

Senior Manager, Clinical Data Management

Marketing Operations

• Drive effective and efficient promotional material review and material fulfillment services in support of the launch and ongoing support of Celcuity’s products within the U.S.
• Collaborate with cross-functional partners including Marketing, Sales, Market Access, Learning & Development, Legal/Compliance, Medical Affairs, and Regulatory Affairs
• Lead promotional review committee (PRC) team activities and support daily operations
• Partner with cross-functional teammates, including Medical, Legal, Regulatory, Marketing, Market Access, and Sales Training
• Develop agendas and facilitate live PRC review meetings
• Route materials for review and approval in Veeva PromoMats
• Manage the material lifecycle, including expirations and reapprovals
• Support launch readiness tracking and manage reviewer workload
• Support OPDP 2253 submission planning and preparation
• Manage print production process in coordination with fulfillment vendor, internal material owners, and creative agencies
• Manage print and digital material fulfillment via webstore
• Support sales-led conference sponsorship and attendance
• Support speaker program operations
• Other duties as assigned

Quality Assurance Coordinator

Associate Director/Director, Clinical Data Management

Senior Manager, Clinical Data Management

Senior Manager, Marketing Operations