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6- 12 months freelance position Start Data November / December 2009 Rate E 75 / hour Mainland Europe Purpose of Role: To perform/manage the preparation, readiness and quality control of submission deliverables for the dataset section of regulatory submissions conducted by my client according to Good Clinical Practice (GCP) and department Standard Operating Procedures (SOPs). Job Responsibilities: 1. Ensure published CRT deliverables are in compliance with regulatory agency electronic submission guidance. 2. Work with project teams to provide regulatory electronic submission guidance knowledge related to the requirements for dataset submission deliverables. 3. Follow submission preparation tasks to ensure high quality deliverables that comply with regulatory electronic submission guidance: a. Creation and QC of data definition tables (define.pdf). b. Tracking of all variables in submission datasets as to their source in either annotated case report form, external non-CRF data documentation, common variables documentation, or analysis dataset documentation. c. Documentation of all datasets including algorithms for derived variables, description and purpose of datasets, common variables, retained variables etc. d. CDISC SDTM implementation in submission datasets. e. QC of datasets and programs posted by the SAS Programming group, against table, listing and figure content in corresponding CSR and CRF sections to ensure that submission dataset section supports other clinical submission sections. f. Support implementation of data standardization within project teams. g. Use standard SAS programs or write ad hoc SAS programs for creating, checking submission content. 4. Work with CROs and vendors to ensure that final deliverables for dataset section of deliverables will be compliant with regulatory agency electronic submission guidance when they are preparing for submission, and to ensure that dataset deliverables will not cause submission issues when CDDS is doing the publishing. 5. Investigate, evaluate and propose the use of emerging publishing technologies for use in preparation of dataset section of submission. Essential Skills BS in computer science with course-work in data structures and mathematical / statistical programming. 4+ years SAS programming experience, 1+ years dataset submission experience, and overall 5+ years experience in CRO, pharmaceutical or biotech environment. Competent in SAS programming language and extensions. Thorough knowledge of BASE SAS including SAS Macro required. Experience in CDISC standards (SDTM), S-Plus, Clintrial and Oracle SQL a plus. Understanding of clinical trial process from protocol development to data management, statistical analysis and programming, and submission to regulatory agency required. Project management experience or lead programmer on a project with extensive experience working across different functional areas preferable. If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on. We also have a broad variety of other Biometric specific vacancies available in the UK and throughout Europe. Inclusive of SAS programming, Statistical, Clinical programming, Data Management functions, Regulatory Affairs, Clinical Research, QA, Compliance & Validation. For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]<mailto:[log in to unmask]> James Carrera Tel: +44 (0) 207 255 6665 [log in to unmask]<mailto:[log in to unmask]> http://www.justgiving.com/jamescarrera