Job Description

About the role

Principal Clinical Database Developer
Location - Hyderabad #LI Hybrid

About the Role:
Provides comprehensive expertise for projects/programs involving multiple or complex global clinical studies ensuring consistent and high quality generation of specification, production, and validation of clinical data collection systems and associated metadata with high quality, on time, and within budget in accordance with project budgets. Interpret data collection requirements into data models of moderate complexity and uses relevant programming language to build EDC & warehouse setup.

Key Responsibilities:

• Serves as the primary program/therapeutic area lead ensuring timely and quality deliverables

o Leads the effective and timely development and implementation of clinical systems
o Uses advanced database programming techniques to solve study specific complex validation or custom development needs
o Understand and manages study metadata to compliment data provisioning in compliance with global standards.
o Coordinates database development and conducts database testing
o Develops data models to support data review and acquisition standards to adapt for study/project level needs and specificities.

• 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 quality.
• Lead independently or participate in improvement initiatives and/or non-clinical projects.
• Communicate and ensure that project objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
• Responsible for Database development activities for multiple studies in parallel across TAs Coordinates resources to ensure project objectives are met.
• Contributes to the development/updates of Clinical Systems processes and supports training on systems and processes to ensure compliance. Recruit, train, mentor, supervise and/or coach junior staff.

https://www.youtube.com/watch?v=DOyF_PUfRHc

Role Requirements

Essential Requirements:

• Bachelor\'s degree preferably in computer science, management information systems, or other related area.
• At least 7 years of experience in setup of clinical databases/Data Warehouse using RAVE or OC-RDC or LSH. Advanced technical skills: Expert knowledge of EDC - Medidata RAVE preferred
• Excellent understanding of relational databases. Microsoft Office Suite. Knowledge of other programming languages such as SQL, PL/SQL, VBscript, SAS, C# or Java preferred.
• Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment. Excellent problem-solving, project management negotiation and conflict resolution skills
• Excellent understanding of Drug Development Process, ICH-GCP and Health Authority Guidelines & Regulations. Excellent planning, resource and project management skills.
• Ability to mentor within Clinical Sytems and cross functionally and coordinate internal and external training.
• Ability to effectively lead and contribute to initiatives requiring Clinical Database acquisition tools and design expertise.
• Working knowledge of relevant industry standards including CDASH and SDTM is preferred. Subject Matter Expert in functional, technical process and provide technical expertise in the establishment of data standards for new study specific CRF pages.

Desirable Requirement:

• Organizational, operational and technical leadership directly impacting business efficiency and quality within DO
• No critical findings as result of internal inspection, routine audits or health authority inspections relating to activities/deliverables supported by Data Operations.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people\'s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You\'ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' 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.

Functional Area

Research & Development

Division

Development

Business Unit

GCO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No

Novartis