Possibilities in sight

At lvantis, you’ll have the opportunity to further your potential by joining a team committed to expanding patient treatment and improving outcomes through innovative minimally invasive glaucoma surgical (MIGS) solutions, the fastest growing segment of the ophthalmology market. For a complete list of available career opportunities or to apply for a position listed below, please contact lvantis Human Resources at HR@ivantisinc.com.

Available Opportunities

Job Title: Clinical Data Manager (CDM)

Description

The Clinical Data Manager (CDM) or Sr. CDM is responsible for executing the design, documentation, testing, implementation, and locking of clinical study databases, including managing data entry activities and performing data review and cleaning.

Duties and Responsibilities

  • Develop Data Management Plan (DMP) for new studies and ensure adherence to DMP for ongoing studies
  • Work with vendors to develop clinical database, including development of annotated CRFs and completion of UAT (user acceptance testing), and edit check specifications
  • Assist in designing clinical study documents, including case report forms (CRFs)
  • Perform clinical database management activities, including:
    • conducting data cleaning,  verification, revision and queries;
    • locking CRFs in EDC;
    • maintaining clinical database, such as tracking patient enrollment and data clarification forms;
    • overseeing database audit and lock
  • Support study team in preparing periodic data reports (e.g., patient profiles) for enrollment, adverse events, and study endpoints
  • Participate actively as core member of study team meetings
  • Support study manager, CTA and CRAs in tracking and ensuring the completeness of study data and documents
  • Conduct training for various study personnel related to database activities, including data entry, data queries and data reports
  • Lead the development of SOPs and Work Instructions related to clinical data management

Requirements

Bachelor’s degree or higher in a clinical research, science, or health-related field or relevant experience. CCDM certification a plus.

Minimum 5 years of data management experience.  Experience in ophthalmology and medical devices preferred.

Knowledge and understanding of regulatory requirements for the use of computer systems in clinical trials.

Knowledge of global standards related to clinical study data management activities (CRF design, data standards (e.g., CDISC), database design, coding and coding dictionaries, etc.).

Experience with database systems such as MedNet, iMedNet, Medrio, ClinCapture, or Access.

Job Title: Quality Inspector

Description

Quality Inspectors are responsible for inspecting, recording, and identifying the status of incoming materials, subassemblies and final products according to written inspection procedures and engineering drawings. Inspection activities include visual and microscopic inspection using visual aids, dimensional measurements using metrology equipment, physical testing using laboratory equipment, and review of supplier, manufacturing, and inspection records.

Senior Quality Inspectors are also expected to work independently; to perform more complex inspections, to train other inspectors, and to support nonconformance, CAPA and complaint investigations.

Lead Quality Inspectors are also responsible for scheduling inspection activities, interfacing with operations and engineering departments and monitoring product quality and departmental performance metrics.

Duties and Responsibilities

  • Receiving and inspecting incoming raw materials, and components
  • Inspecting and testing in-process assemblies and final product
  • Performing first article inspection of raw materials and components
  • Documenting and maintaining inspection and test records
  • Transferring, releasing or quarantining material physically and in the ERP system according to inspection status
  • Reviewing supplier and production records for completeness and conformance to requirements
  • Performing other QA activities as assigned
Job Title: Manufacturing Assembler

Description

To manufacture quality medical device assemblies with a strong adherence to the quality system.

Duties and Responsibilities

  • Perform Line Clearance and complete a lot history record
  • Read and follow manufacturing documentation
  • Follow and adhere to a quality system to produce quality products
  • Maintain a high level of quality work
  • Maintain a good level of productivity
  • Move to various assembly stations to perform different tasks
  • Work with the assembly of new R&D products into manufacturing
  • Receive and identify incoming raw materials, components, and finished assemblies
  • Perform 1st article inspection on raw materials/components according to written procedures
  • Inspect and test in-process and final assemblies according to written procedures
  • Maintain inspection and test records for raw materials/components
  • Generate non-conforming material reports (NMR) and initiate Material Review Board (MRB) for non-conforming materials
  • Perform other QA and related activities as assigned
  • Shipping and Receiving