Clinical Informatics Executive

Associate Clinical Database Programmer

Job Description Summary

The Associate Clinical Database Programmer is providing support or is responsible for LSH and Data Loading Activities (both Inbound and Outbound) with External Data sources of study-level deliverables under guidance. The position is a contributor role in ensuring that pharmaceutical druq-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables.

Job Description

Major accountabilities:

Contibute to LSH and Data Loading activities as Associate Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development. 2. Understanding different formats that can be supported for both Inbound and Outbound data. 3. 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. 4. Should be able to review job logs, Error/failure notifications, follow Blinding process of Third Party data. 5. Build and maintain effective working relationship with cross-functional team. 6. Comply and adhere to Novartis SOPs with standards and processes to support the LSH Setup and Data Loading Activities. 7. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications. 8. Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups. 9. Extend knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM), attend functional meetings and trainings.

Key performance indicators:

Quality and timeliness of statistical programming deliverables and contributions as assessed by the Lead Programmer/Trial Programmer and the functional/operationalmanager.

Effectiveness of communication and team behaviors as assessed by the cross-functional team members.

Minimum Requirements: Education (minimum/desirable):

Languages: Experience/Professional requirement: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field Fluent English (oral and written).

1. 0 to 2 years of experience in a programming role preferably supporting clinical trails or atleast initial work experience as Intern/Trainee.

2. Basic understanding of Mapping, ETL or Data Warehousing activities.

3. Basic understanding of Metadata Standards Management like CDISC SDTM, LSH.

4. Excellent knowledge of Global Clinical Trial Practices, procedures and Data presentation.

5. Basic understanding of related applications that are Data collection tools (like OC, Rave) and ancillary data.

6. Basic understanding of Regulatory requirements.

7. Basic communications and negotiation skills, ability to work well with others globally.

Skills Desired

Clinical Trials, Computer Programming, Data Analysis, Programming Languages

Experience Level

Mid Level