Clinical Programmer

Worldwide Clinical Trials; Thiruvananthapuram; On-site; INR 600,000 - 900,000; Full time

Job summary

Worldwide Clinical Trials in India coordinates and executes processes for configuring, maintaining and validating databases and related systems. You will review specifications, develop SAS programs, and ensure data quality with sponsor and site coordination.

The role requires a degree, experience with Data Management Systems and CDISC SDTM, and strong communication and problem-solving skills. A methodical, detail-oriented approach is essential.

Qualifications

• Degree level required; field not specified.
• Experience with Data Management Systems and software.
• Knowledge of CDISC SDTM standards.
• SAS programming experience is required.
• Promotion is based on proven competency, not years of experience.

Responsibilities

• Coordinate tasks, establish timelines, report progress.
• Review specifications for data entry software setup and edits.
• Review validation plans for edit and reconciliation checks.
• Develop, test and run SAS programs for data management.
• Configure DM/eDC software for DM, sponsors and sites.
• Test databases and related applications per SOPs.
• Liaise with 3rd party vendors to resolve issues.
• Support DM in procedures and documentation.
• Assist with QA and Audit requirements.
• Perform other duties as assigned.

Skills

Communication

Problem solving

Attention to detail

Data quality

Teamwork

Adaptability

Customer focus

Education

Bachelor's degree

Tools

SAS programming

Data management software

Job description

Job Summary

To co-ordinate and perform processes associated with the configuration, maintenance and validation of databases and database systems and associated applications.

Responsibilities

• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To review specifications for the set-up and modification of project specific data entry software (including edit check specifications).
• Review validation plan for edit check and reconciliation check specifications.
• Develop, test and run SAS programs for clinical data management. This includes programs for data validation and reconciliation checks, data listings and data transfers.
• To configure database/eDC software (both internal and 3rd party) for the use of DM, sponsor and sites
• To perform testing of databases and related applications according to IT and Data Management departmental SOPs, both for initial set-up and maintenance.
• To run database upload programs and to process any error reports.
• To liaise with 3rd party vendors to resolve issues, implement changes to software
• To liaise with Sponsors or their designates on matters associated with the transfer of electronic data to or from the company, as defined by the Director, Data Management.
• To support DM in the production and maintenance of system procedures and documentation
• Assist with Quality Assurance and Audit requirements
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other Skills and Abilities

• Be able to demonstrate good written and verbal communication skills.
• Be able to demonstrate a methodical and logical approach to problem solving and the ability to learn new tasks quickly.
• Be able to work with close attention to detail
• Be questioning about the validity of data being entered/extracted.
• Be hardworking and efficient.
• Possess good team working skills.
• Key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
• The job holder must be computer literate and numerate with a willingness to adapt to various computer systems

Requirements

• Be educated to degree level
• Have a experience of Data Management Systems and Software
• An understanding of CDISC SDTM standards
• Experience of SAS programming language
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility to work independently.