Senior Clinical Data Co-ordinator

Worldwide Clinical Trials; Ernakulam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Data Management professional to coordinate configuration, maintenance, and validation of databases and related applications. You will collaborate with staff to allocate tasks, establish timelines, and report progress, while mentoring Clinical Database Programmers in SAS programming and database configuration.

The role requires 5+ years in Data Management Systems, knowledge of CDISC SDTM standards, and extensive SAS programming experience.

Qualifications

• 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

Responsibilities

• Coordinate tasks with staff, establish timelines, report progress and issues.
• Mentor Clinical Database Programmers in SAS programming and database configuration.
• Mentor Data Management staff in database specifications and SAS programs.
• Review set-up specifications for project data entry software, including edit checks.
• Review validation plans for edit check and reconciliation specifications.
• Develop, test and run SAS programs for clinical data management, including data validation and transfers.
• Configure database/eDC software for DM, 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.
• Support Sponsors on data transfer matters as defined by the Director, Data Management.
• Assist with QA and Audit requirements.
• Perform other duties as assigned.

Skills

Written & verbal communication

Problem solving

Attention to detail

Teamwork

Learning agility

Education

Degree level or relevant experience

CDISC SDTM standards

Tools

SAS programming language

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 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.