Clinical Programmer - India

Flex and Oncology Clinical Research Private Limited; Ernakulam; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Data Management professional to coordinate data activities, develop SAS programs, and validate data across databases and eDC platforms. You will work with staff, sponsors, and vendors to ensure accuracy, quality, and timely data delivery.

The role requires a degree and experience with CDISC SDTM standards and SAS programming, focusing on data integrity, validation processes, and system configurations within a clinical data management environment.

Qualifications

• Be educated to degree level.
• Have experience of Data Management Systems and Software.
• An understanding of CDISC SDTM standards.
• Experience of SAS programming language.

Responsibilities

• Coordinate with staff to assign tasks, set timelines and report progress.
• Review specifications for data entry software setup and modification.
• Review validation plans for edit check and reconciliation specs.
• Develop, test and run SAS programs for clinical data management, including validation and data transfers.
• Configure database/eDC software for DM use with sponsor and sites.
• Test databases and related applications per SOPs for initial setup and maintenance.
• Liaise with 3rd party vendors to resolve issues and implement changes to software.
• Interact with Sponsors on data transfer matters as defined by the Director, Data Management.
• Support DM with system procedures and documentation; assist QA and audits.

Skills

SAS programming language

Data Management Systems

CDISC SDTM standards

Attention to detail

Education

Bachelor's degree or equivalent

Job description

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

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 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.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide!

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.

We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.

We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better.

We were founded on an unwavering commitment to authentic, personalized attention.

And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.

We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.