Senior Clinical Database Developer
- Hyderabad, India
4^4 - The number of projects that you would lead or support across multiple therapeutic areas.
We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation , Reporting & Analytics & provisioning of data to downstream applications & teams.
Your responsibilities include, but are not limited to:
• Serves as the primary study lead ensuring timely and quality deliverables
a. Leads the effective and timely development and implementation of clinical systems for assigned studies
b. Uses advanced database programming techniques to solve study specific complex validation or custom development needs
c. Understand and manages study metadata to compliment data provisioning in compliance with global standards.
d. Coordinates database development and conducts database testing
e. Develops data models to support data review and acquisition standards.
• Establishes and maintains strong working relationships with study teams, and functional lines.
• Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, database programming, edit check programming, report programming, electronic data load, interactive response technology, electronic patient reported outcomes, metadata management and other clinical database development activities.
• Ensures that systems meet regulatory requirements, internal standards and are deployed with exceptional quality eliminating post production changes.
• Lead independently or participate in improvement initiatives and/or non-clinical projects.
• Communicate and ensure that study objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
• Responsible for multiple studies in parallel with minimal supervision/ mentoring.
• Coordinates resources to ensure study objectives are met. Contributes to the development/updates of Clinical Systems processes and supports training on systems and processes to ensure compliance.
• Bachelor's degree preferably in computer science, management information systems, or other related area with at least 5 years of experience in setup of clinical databases/Data Warehouse using RAVE or OC-RDC or LSH.
• Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally
• Advanced technical skills: a. Expert knowledge of EDC - Medidata RAVE preferred b. Excellent understanding of relational databases c. Microsoft Office Suite d. Knowledge of other programming languages such as SQL, PL/SQL, VBscript, SAS, C# or Java preferred e. Experience in Custom Functions is an added advantage. ]
• Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment. Excellent problem-solving, project management negotiation and conflict resolution skills
• Good understanding of Drug Development Process, ICH-GCP and Health Authority Guidelines & Regulations.
• Ability to mentor within Clinical Systems and cross functionally, and coordinate internal and external training.
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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