Field Based Remote Position - Home office based (Travel: 30%). Ideally this person would live near a major airport for travel requirements. The Project Manager Country Operations (PMCO) is responsible for the successful execution of study deliverables and the quality execution of protocol procedures, adherence to good clinical practices (GCP) and evolving regulatory requirements, and ensure...

Duties: Clinical Project Lead (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors. Direct the execution of clinical trial activities in accordance with Client SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of...

The position is in the Global Quality Enterprise GxP e-Systems department within the Data Integrity Governance group and is responsible for driving the implementation of an effective GxP Data Integrity Governance Program (the Program) across the end-to-end (R&D, Operations and Supply Chain) product lifecycle to ensure that regulatory and requirements are addressed in a thorough effective, and...

A Principal Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete...

Duties: Use deep process knowledge and experience to assist business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements. Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems...

The R&D Quality (RDQ) Management System/Electronic Document Management System (eDMS) Lead will manage the key process and system changes within RDQ that assures R&D employees perform their work in a consistent, high quality manner. This involves providing strong Process and Technical skills to drive implementation of both our Quality Management System (Procedural Document, Training, Audit,...