Senior Clinical Database Programmer

Worldwide Clinical Trials; Ernakulam; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Worldwide Clinical Trials in India seeks a Senior Data Management professional to coordinate and perform processes for configuring, maintaining and validating databases and related applications, including SAS programs.

Requires at least 5 years in Data Management, knowledge of CDISC SDTM, and strong communication. Be ready to mentor junior staff and ensure data quality for clinical studies.

Qualifications

• Requires 5+ years of experience in Data Management.
• Proficient in SAS programming and data validation.
• Knowledge of CDISC SDTM standards.
• Experience with SAS programs and data management workflows.

Responsibilities

• Coordinate allocation of tasks and establish timelines.
• Assist in training and mentoring Clinical Database Programmers and Data Management staff.
• Review specifications for set-up of data entry software and edit checks.
• Develop, test and run SAS programs for data validation and transfers.
• Configure database/eDC software for DM, sponsor, and sites.
• Perform testing of databases per SOPs.
• Liaise with 3rd party vendors and sponsors on data transfers.
• Support development of system procedures and documentation.
• Participate in QA and audit requirements.

Skills

SAS programming

Data management systems

CDISC SDTM standards

Analytical thinking

Education

Bachelor's degree or equivalent

Tools

SAS

EDC systems

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials , we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.*SUMMARY: To co-ordinate and perform processes associated with the configuration, maintenance and validation of databases and database systems and associated applications. * *RESPONSIBILITIES:* _Tasks may include but are not limited to:_ To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding. To assist in training and mentoring Clinical Database Programmers in the configuration of databases and development, testing and running of SAS programs. To assist in training and mentoring Data Management staff in the specification of databases and SAS programs. 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 Data Management in the production and maintenance of system procedures and documentation in accordance with applicable SOPs. 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 or relevant experience At least 5 years 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, and ability to work independently. The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needsDiscover the DifferenceWe love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers , or connect with us on LinkedIn .