Senior Clinical Database Programmer

Worldwide Clinical Trials; Thiruvananthapuram; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Worldwide Clinical Trials in India seeks a Clinical Data Management professional to coordinate configuration, maintenance and validation of databases and SAS-based workflows. You will mentor DB programmers and DM staff, review specs for data entry software, and ensure adherence to validation plans and SDTM standards.

You will develop and test SAS programs for data management, liaise with Sponsors on data transfers, and support QA/audit requirements while working with a global, diverse team.

Qualifications

• Be educated to degree level or relevant experience.
• At least 5 years experience of Data Management Systems and Software.
• Experience with CDISC SDTM standards and SAS programming.

Responsibilities

• Coordinate and perform processes for configuration, maintenance and validation of databases and database systems and associated applications.
• Mentor Clinical Database Programmers in database configuration and SAS program development, testing and running.
• Mentor Data Management staff in database specifications and SAS programs.
• Review specifications for setup/modification of project data entry software and validation plans for edit/reconciliation checks.
• Develop, test and run SAS programs for data management, including data validation and transfers.
• Configure database/eDC software for DM, sponsor and sites; perform testing per SOPs.
• Liaise with 3rd party vendors and Sponsors on data transfer matters; support SOPs and audits.

Skills

Data management systems

SAS programming language

CDISC SDTM standards

Communication skills

Attention to detail

Problem solving

Teamwork

Education

Bachelor’s degree or equivalent experience

Tools

SAS

eDC software

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 needs

Discover 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.