Clinical Data Standard Expert

Responsibilities

Support the continuous improvement and evolution of clinical standards framework across all functions in Clinical Development.Collaborate with stakeholders to develop standard electronic Case Report Forms (eCRF) in the eCRF system and associated documentation.Support the development of unique eCRF forms for new studies to ensure their compliance with the CDISC clinical data acquisition harmonization (CDASH) and SDTM data standards.Support the set-up and manage the maintenance of an eCRF global library; including appropriate documentation.Publish clinical data standards for data collection and datasets (templates, forms, mapping specifications etc.) with the library.Manage the lifecycle of standards and their documentation and ensure alignment with industry standards and best practices.Implement, communicate, and train Clinical Development on new and revised data standards.Support the development of acceptances criteria for clinical data deliveries to enable adequate quality control of vendor deliverables.Ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (ie, follow the CDISC standard requirements).Serve as a Knowledge Expert to Clinical Development Teams to supports electronic submissions to regulatory authorities with in-depth knowledge of applicable regulatory guidelines and standards. Ensure that clinical program teams consider applicable guidelines and standards in the clinical development plan by giving appropriate advice.Contributes to the development and maintenance of Data Management, Clinical Programming and cross functional procedural documents to govern the development and maintenance of data related standards and processes.

Experience

At least 8 years of experience in either clinical data management and/or statistical programming, within the CRO/pharmaceutical environment.Must have a comprehensive understanding of data management processes and standards as well as current regulatory requirements for data management and data standards for submission.Must have a comprehensive understanding of interdependencies of processes in the clinical development process.Knowledge of at least one widely used CDMS and preferably experience of working with an EDC platform (Medidata Rave preferred).Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.Experience in working in cross-functional, multi-cultural and international clinical trial teams.

Competencies

Excellent communication and analytical skills.Strong planning and organizational skills.Ability to work successfully in a matrix organizational structure.Exhibits strong negotiation skills and is able to identify and engage internal and external expertise as needed.Proven networking skills and ability to share knowledge and experience amongst colleagues.Fluent in English, oral and written.