Clinical Programmer

1 week ago

Hyderabad, India Novartis Full time

The number of projects that you would lead or support across multiple therapeutic areas.- Your responsibilities include, but are not limited to:
- Contribute to LSH and Data Loading activities as Associate Clinical Programmer for phase I to IV clinical studies in Novartis Global Drug Development. Participate in the review of Data Transfer specification documents and provide comments if required. Also perform Data Loading activities so that data flow is available once the third-party data is obtained from external vendors. Address QC findings prior to Production Loads.
- Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models). Responsible for Study Conduct activities that includes Conformance of Clinical data to internal Novartis data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders.
- As part of the Setup activities, responsible for the maintenance and daily operational support that includes Data processing activities during Study conduct like reviewing Job Logs, address Error/Failure notifications, blinding process of Third-Party Data. Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third-Party Vendors.
- Need to have good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables.
- Participate in all Subject matter expert (SME) activities and help on any functional testing activities. Build and maintain effective working relationship with cross-functional team.
- Comply and adhere to Novartis SOPs with standards and processes to support the LSH Setup and Data Loading Activities. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications.
- Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups.
- Under mínimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance. Contribute to assigned parts of process improvement, standardization, and other non-clinical initiatives

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- 2-5 years of work experience in a programming role preferably supporting multiple clinical trials across various therapeutic areas.- Good understanding of Mapping, ETL or Data Warehousing activities.
- Good understanding of Metadata Standards Management like CDISC SDTM, LSH.
- Good knowledge of Global Clinical Trial Practices, procedures, and Data presentation.
- Good understanding of Regulatory requirements.
- Good communications and negotiation skills, ability to work well with others globally

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 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
- 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.**Division**
- Global Drug Development

**Business Unit**
- GDO GDD

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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