Location
Bangalore | India
Job description
The EDC Study Programmer I will play a crucial role in collaborating with both Sponsor and Sitero study teams to design, develop, and maintain EDC and eConsent databases, ensuring data quality, user experience, and regulatory compliance. The candidate will also be responsible for creating and validating edit checks based on specifications and addressing post-production changes in live studies. A strong understanding of EDC, eConsent, and related software, along with adherence to Siteros standards, is crucial for this position.
Primary Responsibilities
Designing and developing eCRFs/Study Database:
- Interacting and collaborating with other study team members (Sponsor and Sitero) to support the build and maintenance of EDC studies to ensure quality data collection, user experience and regulatory compliance.
- Designing and developing eCRFs/Study Database based on Sponsor and Internal Clinical Data Management (CDM) provided documents such as the study protocol and other additional documentations as applicable.
- Working with the Sponsor and Internal CDM teams to ensure consistency of eCRFs with past studies and adherence to Sitero standards and libraries.
- Reviewing and incorporating Testing/UAT feedback on Study Design and eCRFs from EDC SPQC, Internal CDM and Sponsors team members.
- Maintaining a strong understanding of EDC, supporting software and internal standards.
- Maintain and contribute to Sitero library of standard EDC CDASH compliant CRFs.
Designing and developing Edit Checks by:
- Interacting and collaborating with other study team members (Sponsor and Sitero) to support the build and maintenance of edit checks to ensure quality data collection, user experience and regulatory compliance
- Writing, validating, and implementing applicable edit checks based on the specifications provided by Sponsor/Internal Clinical Data Management teams.
- Reviewing and incorporating Testing/UAT feedback on edit checks from EDC SPQC, Internal CDM and Sponsors team members
- Developing custom reports based on project management requests.
Provides support for studies in production by:
- Supporting Project Management with post-production changes (Impact Analysis) that are not directly related to protocol amendments or study configurations, for ex: duplicate resolutions, subject data transfers etc.
- Investigating, identifying and escalating EDC bugs to the product manager.
Designing and developing eConsent:
- Interacting and collaborating with other study team members (Sponsor and Sitero) to support the build and maintenance of eConsent studies to ensure quality data collection, user experience and regulatory compliance.
- Designing and developing eConsent Database based on Sponsor provided documents such as the ICF and other additional documentations as applicable.
- Reviewing and incorporating Testing/UAT feedback on eConsent documents from EDC SPQC and Sponsors team members.
- Maintaining a strong understanding of eConsent, supporting software and internal standards.
Secondary Responsibilities
Maintains Quality Service and Departmental Standards by
- Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP )
- Establishing and enforcing departmental standards
- Reviewing and updating company SOPs related to Study Operations
Contributes to team effort by
- Exploring new opportunities to add value to organization and departmental processes.
- Helping others to accomplish results.
- Performing other duties as assigned and deemed necessary.
Maintains Technical Knowledge by
- Attending and participating in applicable company sponsored training.
Qualifications:
Education:
- Bachelor s degree in computer science or a related field.
- Working knowledge of programming/markup languages like .NET, XML, C++, Java, SQL or Python
Experience:
- 3+ years of relevant programming experience in similar EDC systems like Medidata RAVE, Veeva EDC or others.
Additional skill set:
- Working knowledge of CDASH/CDISC standards
- Working knowledge of eClinical systems (EDC, IRT and CTMS)
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and leadership skills
- Strong Critical Thinking skills
- Ability to maintain professional and positive attitude
Job tags
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