Roles & Responsibilities: Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enter...
Responsibilities: This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational...
Responsibilities: Prepare, review, and submit regulatory documents to FDA. Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals. Ensure that all products comply with applicable regula...
Responsibilities: We are seeking a skilled Clinical Data Management Lead to oversee the execution of clinical trials. This role will be responsible for ensuring high-quality data collection, review, and delivery within scope, on time, an...
Responsibilities: Our client is searching for a Quality Engineer to support various activities for their specimen management instruments. This role is critical in ensuring the ongoing quality and compliance of supplier-provided component...
Roles & Responsibilities: 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems. Perform review for GxP systems to ensu...
Responsibilities: Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP. Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADAM datasets. Execution of validation and...
Responsibilities: Have a strong understanding of CSV, as well as CAPA's, investigations, deviations. Help manage projects from concept through to completion, ensuring timely delivery of milestones and results. Utilize strong problem-sol...
Responsibilities: Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plan, coordinate, and deliver compl...