Senior Global Trial Specialist

Location:5 Giralda Farms, Madison, NJ 07940Support the start up maintenance and close out of global clinical trial studies. Coordinate and provide operational excellence in planning, initiating, conduct and close-out of multiple interventional and non-interventional global pharmaceutical trials in accordance with the lifecycle phases of the trials (Phases – I, II, III, IV) under the late development setting (Interventional studies, non-interventional registries, Post-authorization Safety Studies (PASS), pre-clinical studies). Provide technical review of pharmaceutical trial data or reports that will support the progress of the study, in any regulatory submissions if applicable. Participate in user acceptance testing of databases being used to capture patient data, the quality oversight of data, and third-party activities that provide support in data management and clinical site monitoring. Document internal regulatory processes, assisting in audits, inspections and providing guidance in regulatory submissions for initiating a clinical study and any recommendations from health authorities. Assist the Global Trial Manager in driving study execution. Identifies potential risks and develop actions to avoid or mitigate. Resolve routine problems and escalate important issues appropriately. Perform core Global Trial Specialist tasks – Clinical Trial Management Systems and Trial Master File operations expert. Escalates/pushes back/delegates when appropriate. Contributes study meetings by providing updates related to Global Trial Specialist responsibilities/deliverables. Provide operational input to study tools/plans and participates in operational processes in support of the startup, maintenance and close out of studies with moderate to minimal supervision. Assist the Global Trial Manager in driving study execution. Raise potential issues for escalation to the appropriate stakeholders. Manage applicable attributes and milestones/drivers in Clinical Trial Management Systems Manage the development and/or collection of applicable documentation. support Global Trial Manager in ensuring Electronic Trial Master File accuracy and completion for all studies.As applicable, manages the global setup of study level non-clinical supplies. Develop, update, and submit Transfer of Obligations to Regulatory Authorities. Generate and manage reports and lists relative to the assigned studies. Manage study mail-groups/distributions and SharePoint/Study Directory updates. Participates in filing activities and any associated audits/audit reponse. Manages vendors and site payment processing and tracking. Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports. May work remotely 5 days every 2 weeks within normal commuting distance of Madison, NJ.Requirements: Bachelor’s degree (or foreign equivalent) in Pharmacy, Clinical Research or Healthcare, or a related field plus 1 year of post-baccalaureate experience in clinical research. Experience must include the following: •Pharmaceuticals for Human Use/ Guideline for Good Clinical Practice (ICH/GCP), •regulatory guidelines/directives/ drug development•Clinical Trial Management System (CTMS) •electronic Trial Master File•Clinical Trial processes and management•data mining•risk analysisThe skills, knowledge and/or experience need not be maintained over the full term of experience required.