Manager, Clinical Programming

Worldwide Clinical Trials; Thiruvananthapuram; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Worldwide Clinical Trials in India seeks a senior leader to manage and guide the Clinical Database Programming team, ensuring accurate, timely delivery of programming deliverables for clinical studies.

You will develop the team, allocate tasks, review specifications, oversee EDC development, and collaborate with Sponsors and DM leadership to maintain data integrity and quality. The role requires extensive SAS experience and CDISC SDTM knowledge.

Qualifications

• Be educated to degree level or relevant experience.
• At least 2 years management experience.
• Have at least 8 years plus experience of Data Management Systems and Software.
• An understanding of CDISC SDTM standards.
• Experience of SAS programming language.

Responsibilities

• Lead and develop the Clinical Database Programming team to ensure timely, accurate deliverables.
• Allocate tasks, establish timelines, and report progress and issues.
• Assess technical merits and changes to software applications/databases.
• Manage EDC development work to achieve timely delivery.
• Review specifications for data entry software and edit checks.
• Configure database/EDC software for DM, sponsors and sites.
• Perform testing of databases and related applications as per SOPs.
• Coordinate with 3rd party vendors to resolve issues and implement changes.

Skills

Leadership

Communication skills

Problem solving

Attention to detail

Teamwork

SAS programming

CDISC SDTM

Education

Degree or relevant experience

Tools

SAS

Job description

Job Summary

To provide management and leadership of the Clinical Database Programming team; ensuring the efficient, accurate and timely management of Clinical Database Programming deliverables.

Responsibilities

• Proactively manage and develop the performance of Clinical Database Programmers through performance management, capability, training and development to meet the needs of the business.
• To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
• To assist with assessing the technical merits and development of, and changes to, software applications and databases (both internal and 3rd party).
• To manage EDC development work allocated to the Clinical Database Programmers in order to achieve timely delivery.
• 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.
• 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.
• Develop and maintain database libraries in assigned applications.
• Be involved in ongoing planning, progress reporting, monitoring of systems and study metrics.
• Be involved in the development and technical leadership of new processes and implementation of new solutions.
• 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.
• Ability to demonstrate a methodical and logical approach to problem solving and the ability to learn new tasks quickly.
• Ability 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 2 years management experience.
• Have at least 8 years plus 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.