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Purpose of Job Briefly state the primary purpose of the job in terms of how it contributes to the departments objectives : This position requires strong data management knowledge and skills. Senior Clinical Data Manager lead data management activities for projects involving multiple and or complex clinical studies, including global studies. They are able to work without close supervision and can coordinate the activities of other junior staff members. Job Components List the major job responsibilities and accountabilities in order of priority;..

CONTRACT: SAS Programmer II 6 month++ based in South UK Job Summary: To plan, develop and execute statistical programs designed to analyse clinical trial data. To assist experienced staff in planning, development, validation of project level programs and macros. Accountabilities Responsibilities: *Responsible for the planning, development and execution of study level validated programs for analysis data sets, tables, figures and data listings for a clinical trial *Assist in the planning, development, validation of project level programs and..

Accountabilities Responsibilities: *Draft statistical text for study concept documents and protocols study design, endpoints, sample size, methods for analysis *Draft statistical analysis plans *Draft templates for tables, listings and graphs *Draft SDF dataset specifications *Assist in the review of key study-related documents produced by other functions e.g. CRFs, Data Management Plans etc *Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs mostly statistical analysis outputs, some..

CONTRACT: Statistical SAS Programmer Analyst Department of Biostatistics & Epidemiology Based in the UK - 6 month rolling contract Job Summary: Working for this major client, you will ensure; *all programming outputs pertaining to individual clinical studies and ISS ISE meet required standards and are validated correct *all programming outputs pertaining to non-registrational activities meet required standards and are validated and correct *quality and accuracy of programming deliverables. Accountabilities Responsibilities: *Assist in the..

Working for this London based client you will provide statistical input into Phase I-IV clinical trial development, performing analysis of clinical trial data and provide statistical input into the reporting of clinical trial results Accountabilities Responsibilities: *Provide statistical input into protocol CRF development in all therapeutic areas *To ensure the Master Study Files are maintained throughout the study *Write detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and..

Accountabilities Responsibilities: Co-ordinate all pharmacovigilance QA activities Liaises with contract auditors to co-ordinate pharmacovigilance audit activities Development and execution of internal pharmacovigilance audit programmes Co-ordinate pharmacovigilance contracted Auditors and QC of audit reports generated by QA contractors Propose audit schedule and co-ordinate with GCP and GMP Audit schedules including coordination of schedules Design and implement a pharmacovigilance QA strategy to include a risk-based..

Office Based Medical Devices Clinical Research Associate II - South West England Position Summary: As the Clinical Research Associate you perform all assigned activities and operational processes associated with clinical investigation study management Coordination and supervision including design, implementation and conduct of clinical investigations. The primary focus of the position is to assure compliance with sponsored clinical investigation protocols, company SOPs, EU and other national regulations guidance, GCP and manage multiple study..

Accountabilities Responsibilities: *Represent the statistics function on global teams in support of clinical studies and programs led from either the US or EU. *Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. *Provide accurate, statistically appropriate outputs included in protocols, statistical analysis plans, study reports and regulatory submission documents. *Oversee definition and implementation of project level database including derived database ,..