electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring...This role requires 4-days onsite in our Cambridge, MA office. Fully remote is not eligible. The Senior Clinical Study...
control. Represent Clinical Quality Compliance in these topics in inspections. Support and provide relevant guidance... of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global...
required to support the business of the Commonwealth, to make a difference in the lives of children by enforcing the financial... and enforcing tax, child support and municipal finance laws in ways that are innovative, customer-focused and transparent...
, available for work and looking for a job. The Revenue Audit, Enforcement and Tax Integrity Manager is a crucial managerial position... a critical role in combating employer fraud, managing audit, collection and enforcement efforts. Develops new processes...
: Purpose of the position § Assists and provides support to the members of the clinical operations study team in administrative... § Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection § Contributes to clinical trial excellence...
provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending... administrative and technical support by performing day-to-day functions within the client organization to support clinical trial...
Job Posting Category Nursing Job Posting Description The Clinical Documentation Integrity Educator is responsible... for: Serving as the lead for internal staff education in this new role for the Department of Pediatrics, develop prescriber...
reviews, risk reviews, and other clinical level quality reviews globally or locally. May lead country/region specific quality... and other stakeholders and functions such as Risk based Quality Management Serve as the quality expert for global and local clinical quality...
manufacturing facilities. Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation... of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines...
We are seeking a seasoned QA Inspection Readiness Consultant to lead and support audit and inspection readiness..., Clinical, Regulatory, Manufacturing, PV, etc.) to drive corrective actions and close identified gaps. Support or lead hosting...
as Regulatory Lead to develop and implement regulatory strategies for assigned highly complex project(s)/product(s) across the... teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications...
to support audit and inspection readiness. PRINCIPAL DUTIES: Essential Document Control responsibilities include: ·Manage..., and document retrieval in accordance with regulations, best practices, and corporate policies and procedures. ·Lead inspection...
current VQM teams. In addition, this role will directly lead a team within RDQ and be responsible for further establishing... about vendor risk that inform audit planning, inspection readiness, and governance strategies employed by quality counterparts...
quality improvement (CQI) initiatives Audit & Inspection Readiness Lead internal audits and mock inspections to assess... solutions serve as a horizontal support hub to empower health system-led, world-class advanced therapy care across 50+ disease...
records are maintained in a compliant and audit-ready manner. Lead or support internal and external audits related... from clinical throughout product commercialization activities, post-approval process monitoring, and deviation management. The role...
system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs throughout clinical.... Ensures appropriate CAPA actions are identified and addressed. Maintains Quality Metrics to support process improvement...
leadership and teams (e.g. audit, vendor management) in development of integrated strategies for clinical programs, process... Lead for the respective product/program area(s) and have overall responsibility for lifecycle review of risks to quality...
Regulatory Compliance: Ensure compliance with regulatory and Risk Management Plan (RMP) commitments, and support clinical... of pharmacovigilance vendors Audit Support: Conduct PV audits and regulatory inspections Oversight of the PV operational and case...
property filing Support the Team Lead and Controller in annual audit requests Prepare ad-hoc financial analyses/projects... intercompany invoices and wire transfers, and supports Team Lead and Controller in annual audit requests. Position: Staff...
, and any technical reports as needed Support Servier's audit program, including audit preparation, coordination, execution..., assesses phase IV clinical trial design for marketing and medical communication impacts, and evaluate labelling changes...