Fortrea Company would like to appoint 7 employees in Kuwait for the following specializations شركة فورتريا ترغب في تعيين 7 موظفين في الكويت للتخصصات التالية

 

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• Builds client rapport, trust and ongoing relationship, proactively identifying opportunities for new and repeat work
• Leads initial meetings with client to review work plan, timelines, data sources; leads meetings through project duration
• Leads team effort to define project scope, deliverables, budget and timelines; directs proposal writing to respond to client requirements using standard formats
• Oversees others responsible for executing on projects, ensuring data are collected according to Standard Operating Procedures (SOPs) and within agreed upon timelines and budgets; coordinates input from clients, other Fortrea groups and external advisors, and identifies scope changes and whether a change order is required.

• Review SAPs and TFL shells from a programming perspective
• Advise on the development of complex TFL shells from a programming perspective
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
• Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs

Your responsibilities:

• Review SAPs and TFL shells from a programming perspective
• Advise on the development of complex TFL shells from a programming perspective
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
• Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
• Respond to QA and client audits and support qualification audits
• Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business
• Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)

Your responsibilities:

• Review SAPs and TFL shells from a programming perspective
• Advise on the development of complex TFL shells from a programming perspective
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs
• Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
• Respond to QA and client audits and support qualification audits

• Minimum 5-7 years’ experience in the Pharmaceutical industry or Drug Development in Regulatory Affairs
• Excellent communication, organization and planning skills with an attention to detail
• Extensive experience in leading clinical trial applications at a regional/global level
• Direct project management skills and ability to work independently
• Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations in particular
• Bachelor’s degree or higher
• Fluency in English

Main Responsibilities:

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
• Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
• Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
• Support/oversee submission activities (especially in late phase team)

Main Responsibilities:

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc.
• Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs
• Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing and additional development needs and analyses
• Support/oversee submission activities (especially in late phase team)