Until September 2021
Up to £55 per hour via umbrella only
Remote / Brentford
• Plans and participates in programming/QC activities for multiple studies or across an indication including submission activities. Contributes to standards within a therapeutic area in accordance with the Asset Data Strategy.
• Leads the eCRF Development process.
• Plans and manages the eCRF Development and Post Go Live timelines.
• Provides Technical expertise to internal/external customers in support of clinical study data.
• Provides consultancy with regard to study specific technical activities and issues, i.e., analysis of existing business technology issues and development of plans for capability improvement through increased efficiency or effectiveness.
• Provides Technical consultancy to R&D strategic initiatives and contributes to plans for capability improvement through increased efficiency or effectiveness.
• Leads small non-clinical projects within department and with experience in grade, major projects (clinical or non-clinical), across the wider Programming Community.
• May lead the development of standards- Includes -omics, biomarker, and in-licensed compounds and input into industry standards.
• Able to motivate staff within functional or cross-functional team - may represent the Programming community externally (e.g. FDA teleconferences).
• Be able to resource effectively to meet team milestones, enable prompt decision-making for the projects and to build credibility and presence with customers.
• Influences and adds value (e.g. data visualization) at study team and functional team level to enable decision-making. Utilizes other disciplines outside of the programming area to solve complex problems; proactively identifies technical programming problems; define criteria for assessing alternative solutions & determine the optimal approach; make decisions in face of unusual and conflicting information.
• Identifies recurring problems and initiates process improvement. Proactively identify, assess and resolve the impact of decisions/actions from other groups.
• Appreciation of future direction/wider objectives (project or business).
Education / Skills:
• Leverages relationships to address Project / Study issues.
• Delivers all communication with clarity, impact and passion and tailored to the audience. Makes complex ideas simple.
• Applies effective verbal and written communications skills at project level and external (e.g. Commercial, Regulatory).
• May present at project level and externally; applies skills at any level with experience in grade.
• Provides broader level knowledge and expertise (e.g., UNIX scripting, computing environments, Data Capture, tools integration, Data Extraction); provides technical advice to other teams/ departments.
• Provides advice on technical issues outside of community (e.g. Global Software Applications, Impact of new software and systems).
• Takes an initiative (a clearly interconnected set of activities) designed to raise the value added to customers.
• Bachelors Degree / Masters Degree or equivalent with proven applicable experience.
• Expertise in SAS.
• Understanding of regulatory process.
• Ability to generate/implement ideas/solutions to cross functional strategy (e.g., outsourcing strategies).
• Anticipate process and software challenges. Expertise in SAS, SQL and/or other scripting and programming languages; Relational Database Design.
• Proficient in SAS
• Proficient in Oncology specific and efficacy domains
• Proficient and significant hands on experience with CDISC ADaM and custom standards
• Thorough understanding of Clinical Trials
• Good communication skills
Good to have:
• HARP experience
• Learn quickly and adapt to always changing requirements
• Ability to create custom SAS Graphs
• Exposure to validation processes
• Comfortable working in matrix environment
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
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