Edc Study Programming Associate

7 months ago

Bengaluru, India Sitero LLC Full time

**Company Overview**:
Sitero is a leading organization specializing in clinical research and healthcare solutions.

We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented EDC Study Programming Associate to join our team and contribute to our mission.

**Position Overview**

**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.

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

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.
- Contributes to team effort by_
- Exploring new opportunities to add value to organization and departmental processes.
- 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**:

- Completed coursework or projects in.NET, XML, C++, Java, SQL or Python

Additional skill set:

- Strong problem-solving capabilities.
- Good communication (both verbal and written) and collaboration skills.
- Eagerness to learn and adapt in a fast-paced environment.
- Ability to maintain professional and positive attitude

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