Clinical Data Programmer II

Novotech; Bengaluru; On-site; INR 800,000 - 1,800,000; Full time

Job summary

Novotech is seeking a Clinical Data Programmer-II to join the Data Management team. The role focuses on programming activities on clinical trial projects and ensuring compliance with GCDMP.

You will design and maintain clinical databases across various EDC applications, annotate CRFs per CDISC guidelines, and support validation and data exchanges with vendors in line with SOPs and ICH-GCP standards.

Qualifications

• Graduate in information science or life science related field.
• Two years experience in a similar role in a CRO or pharmaceutical company.

Responsibilities

• Design and implement clinical databases for projects in accordance with Novotech standards.
• Program data review listings and data reconciliation.
• Design, programming, testing and maintenance of clinical trial databases in various EDC applications.
• Perform external data loads (labs, ECGs) and liaise with vendors to define data transfer specs.
• Ensure all programming activities adhere to SOPs and good programming practices.
• Annotate CRFs per CDISC guidelines with metadata to reflect CRT datasets.
• Provide guidance on interfaces between clinical databases and other systems.
• Support validation of electronic systems to regulatory requirements.
• Assist Project Lead in project meetings and related tasks.

Education

Information science or life science

Job description

Brief Position Description

The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-II (CDP-II) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP).

Responsibilities

• The CDP-II shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP-II shall ensure quality standards per SOPs and ICH-GCP.
• Participates in project team meetings as required.
• The CDP-II shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards.
• Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards.
• Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices.
• Experience in developing, validating and maintaining clinical trials built in different EDC applications.
• Ability to learn new process, programming languages and adapt with new technologies.
• Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.
• To have the technical knowledge and provide guidance on providing interfaces or data exchanges between the clinical database and other database, programming or reporting systems.
• Support in the validation of electronic systems, software and programs implemented in accordance with current regulatory requirements.
• Support on project meetings and telephone conferences where required. The CDP shall support the Project Lead on a project on tasks as needed.

Requirements

• Graduate in information science or life science related field, or similar.
• Two years experience in a similar role in a CRO or pharmaceutical company.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.