Principal Analyst, Database Operations

Job Description

Job Purpose The Principal Analyst (Clinical Data Standards) is responsible for leading the planning, development and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use and in line with the Clinical Data Standards strategy.They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including; Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications Analysis data/TFL standards Associated standard metadata, business rules and guidelines. Your responsibilities include, but are not limited to: Strong knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission. Experience in supporting development of clinical standards and associated guidelines. Expert technical skills relevant to; a. Data Acquisition and Tabulation 1. Good knowledge of EDC systems (preferably Medidata-Rave) 2. Good knowledge in Object Oriented Programming concepts 3. Knowledge of other programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferable Develop the non-standards Annotations; Lead and contribute to Clinical Data Standards definition, development, validation including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable. Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized. Responsible for driving the efficient, high quality and timely implementation of new standards and/or updates to standards 1. Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation 2. Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata). 3. Use advanced database-programming techniques to support the implementation of efficient data collection tools. 4. Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission. In collaboration with representatives across internal teams and across Global, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards. Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed. Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed. Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.Minimum requirements BS/BA/MS in computer science, management information systems, health sciences, statistics, or related field with atleast At least 8 years industry experience in one of the following fields; o EDC development and implementation preferably using Medidata-Raveo Data Management Clinical o Statistical Programming using SAS and CDISC data standards Advanced knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission. Significant experience in supporting development of clinical standards and associated guidelines. Advanced technical skills relevant to;o Data Acquisition and Tabulation EDC systems (preferably including Medidata-Rave) Object Oriented Programming concepts Other programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferableo Data Analysis and reporting SAS and other statistical programming languages/software (e.g. R) Understanding of statistical programming/statistical concepts in clinical trials Other programming languages such as Visual Basic, SQL-PL/SQL, XML, Python preferable Advanced understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH) Excellent project management and coordination skills; Excellent problem-solving, negotiation and conflict resolution skills. Outstanding interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally. Excellent understanding of drug development, global clinical trial / project practices, procedures, methodologies. Proven ability to provide and coordinate internal and external training (Experience working in highly matrix teams and providing technical guidance). Experience contributing to non-clinical initiatives requiring Clinical Standards expertise highly preferable.Why Novartis 769 million lives were touched by Novartis medicines in 2020, and while we re proud of this, we know there is so much more we could do to help improve and extend people s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
researchaccountingclient managementconsultingmarket researchobject oriented programmingmanagement information systemsdata modelsvisual basicstatements of work sow