400 active trials, Novartis GDQ is committed to delivering support to make the clinical trial process more efficient and patient-friendly. We are in search of those who are passionate about applying their experience to support and drive innovation with quality process.
Your responsibilities include, but are not limited to:
• As Global Development Quality (GDQ) representative, support the Global Drug Development (GDD) key business processes related to Database Development, Data Management, Statistical Programming and Analytics by providing expertise and guidance to ensure that clinical data flow, management & analysis processes are fit for purpose and meet Novartis standards, Health Authorities regulations and GCP guidelines. Engage with GDD business and quality teams to identify potential quality risks and provide guidance to business on the control and mitigation measures.
• Provide quality advice and oversight to ensure required standards and regulations are followed during end-to-end data flow and data analysis processes (e.g. development of study into electronic data capture systems, study build/ conduct/ close out, statistical analysis and clinical study report development).
• Support relevant Business functions during audit/inspections preparation, response to requests and CAPA creation. Partner across business units/ divisions to support programs to embed and implement digital capabilities, data science and new technology into the drug development and the end-to-end clinical trial processes in scope.
• Collaborate with different functions (e.g. Business Franchises, Global Data Operations Organization, Pharmacovigilance, Clinical, CDE&A, IT, and other teams) to contribute in development of suitable business strategies resulting in a capable, experienced and empowered Database Development, Data Management, Statistical Programming and Analytics organization. Ensure information flow and alignment with internal and external partners/ stakeholders.
• Support GDD and GDQ teams to ensure new processes and technologies are risk-assessed and understood. Provide consultancy on Integration and Due Diligence activities linked to Business Development and Licensing (BD&L) for in scope Business Process and relevant Business Functions.
• Proactively identify regulatory, quality and compliance risks for assigned areas/ activities/projects and support Business to establish mechanisms to mitigate these risks. Ensure Clinical Trial Quality Risk Management concepts are applied as applicable. Provide expertise and guidance to business partners in investigations, root cause analysis and risk mitigation assessments of quality incidents as per and change management process.
• Contribute in cross-functional projects/ workstreams to continuously improve Novartis standards, processes and systems to ensure better process adherence and to simplify the way we work. Provide comments to relevant regulations during consultation period as requested. Support other assigned tasks as required within Gl. GDD Quality Data & Digital Processes scope and deputize for peers and manager as needed.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
• Significant relevant work experience (> 10 years) in the pharmaceutical industry or public health sector, in the area of Clinical Data Management, Statistical Programming, Clinical Database Programming, Quality, Information Technology, Data & Digital and/or Clinical Development.
• Strong background and experience in GCP, PV and other relevant Health Authority regulations, paired with good business understanding. Understanding of CSV and Part 11requirements as well as privacy and information security regulations.
• Exemplary interpersonal skills demonstrating the Novartis values for collaboration, quality and integrity; ability to bridge between quality, scientific and business experts.
• Flexibility in problem solving and providing direction to meet business needs objectives. Ability to innovative when faced with opportunities or challenges.
• High learning agility, comfortable with complexity and diversity, and highly interested in continuous improvement. Excellence in communicating effectively across different audiences and organizational levels.
• High awareness of trends and ability to proactively address needs based on external demands. Proven ability to build strong and effective relationships with internal and external partners. Change management skills to facilitate changes and sustain a culture of high ethical standards and compliance
• Bachelor’s degree in Life Sciences, Statistics, Information Technology or related fields. Master’s degree or equivalent is a plus.
766 million lives were touched by Novartis medicines in 2021, 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 what's 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!
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
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