The Senior Safety Specialist is responsible for ensuring accurate collection, database entry, review, and reporting of clinical trial and post marketing safety data. They will be required to assist senior staff in signal generation, safety analysis activities, and to be proactive in the development and implementation of departmental processes and guidelines. They will be

The Line Manager, Clinical Monitoring FSS (LMCM) is responsible for oversight of all activities related to clinical monitoring as they pertain to a specific client and/or Functional Service Provider (FSP) program. As part of the dedicated client FSP team, the LMCM's responsibilities include but are not limited to resource management, assurance of quality data, and deliver

The Senior Medical Director serves as the primary medical point of contact for a project or study. The Senior Medical Director effectively manages medical and safety review, processes, and projects inclusive of medical and safety monitoring for assigned clinical studies. Responsibilities Assists with RFP/RFI completion and attends sales meetings as requested by Business D

Independent SAS programming QC of summary tables (efficacy, safety, demographics, disposition and exposure) for internally produced displays and displays provided by third party vendors. Generating high quality subject listings and graphs to support safety review. Generating displays to help the clinical team interpret study results and/or query outliers. EXPERIENCE At le

Manage the operational aspects of clinical trials Assist in project planning; timeline preparation, preparation and review of study plans, including the Clinical Monitoring Plan and review of eCRF guidelines/specifications Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project

Provides operational and strategic leadership for Global Safety Services (GSS) to achieve the goals of Advanced Clinical. Manages projects by coordinating the work of the Global Safety Services staff, and if necessary, contractors to assure deliverables meet internal quality standards, are compliant with global Regulatory Authority regulations, are on time, and within bud

Plan and manage study startup including site identification, qualification, selection and initiation activities Lead Clinical Monitoring activities through site activation, maintenance and study closure Develop comprehensive Monitoring Plans (MP) inclusive of but not limited to Monitoring standards (During all stages of the trial) Communication plan Selection, qualificati