Job Description

Summary of Position:

Provides comprehensive expertise for all clinical systems (EDC, CTMS, IRT, etc.). Simultaneously develops multiple or complex global clinical studies ensuring consistent and high quality generation of relational databases and corresponding programmatic validation utilizing standards. Expert in industry standards and metadata to aid in execution of high quality, on time, and within budget deliverables. Interpret data collection requirements into data models of high complexity and uses relevant programming language to design, setup and maintain clinical systems.

Key Responsibilities:

• Responsible for Database development activities for multiple projects in parallel across TAs, including user acceptance testing.
• Uses advanced database programming techniques to solve specific complex validation or custom development needs.
• Responsible and accountable to ensure consistency of standards through technical development, implementation of Industry (CDISC and regulatory) Data Standards and acts as a technical consultant providing standards input to all relevant area data management and reporting areas.
• Understands and manages metadata to compliment data provisioning in compliance with global standards.
• Establishes and maintains strong working relationships within Data Management and collaborates with TDM for database related needs.
• Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, electronic data load, interactive response technology, electronic patient reported outcomes, clinical trial management systems, metadata management and other clinical database development activities.
• Communicate and ensure that project objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
• Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.
• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence.
• Understands Health Authority requirements and ensures adherence to GCP, standards, SOPs/procedures, job aids and guidelines, and is able to prepare for and participate in Health Authority inspections and audits as required.
• Maintain up-to-date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

Key Requirements/Minimum Qualifications:

• At least 5 years of experience in setup of clinical databases/Data Warehouse and standards.
• Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally.
• Advanced technical skills: a. Multi-lingual in programming languages b. Expert knowledge of EDC - Veeva preferred c. Excellent understanding of relational databases d. Microsoft Office Suite e. Knowledge of other programming languages such as SQL, PL/SQL, VBscript, SAS, C#, Python or Java preferred.
• Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment.
• Extensive knowledge of validation procedures and quality assurance.
• Creates and maintains libraries for use in designing, developing, and testing all system components for a trial.
• Excellent problem-solving, project management negotiation and conflict resolution skills
• Bachelor's degree preferably in computer science, management information systems, or other related area. Masters preferred.
• Ability to fluently read, write, understand, and communicate in English

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

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