Merck KGaA

Specialist, Program and Application Development

Posted On

July 3, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Sept. 24, 2024

Job Description

There is a new opportunity for a position as a Specialist, Program and Application Development within Global Development Operations – Data Monitoring, Management & Innovation. The position is specifically aiming at identifying a candidate whth 4-9 years of experience with study database design and maintenance (Rave, Inform, with Medrio as preference).The key accountabilities of the role encompass (among others):Develop, validate, document, and maintain program(s) and applications required to conduct or support clinical data quality checking and surveillance for clinical trials and/or programs, (e.g DQSP, CQR, coding checks, SQSP, SDTM checker, SAE/external data reconciliation, required reports, listings or figures with SAS, R or other programming languages)Create, validate, document, and maintain data conversion programs, follow company level standard.Run (the developed) tools, programs and macros according to timelines communicated by the ordering client/roleAd hoc programming requests (e.g data format transfer and data pooling per request)GeneralContribute to the continuous improvement, re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instructions (WIs) as neededWorks effectively in a mixed environment and uses best practices and knowledge to improve products or services and to define processes and standards.Solves moderate complexity problems based on advanced to sophisticated analytical skills and complex judgement.Accountable for the quality of on-going activities/processes. Receives minimal guidance or works independently.Contribute as team member to DMMI initiativesDevelop experience and skills in new systems when necessaryKeep up to date with job related topics, in particular with regard to SAS, R and Spotfire and other potential language and applicationsDatabase Development:Develop and maintain standard libraries including e-CRFs, edit checks and programs within EDC and other relevant DMMI systems.Deliver high quality and timely database design deliverables and ensure the database readinessConduct system validation as neededMentor other DBDs in all aspects of DMMI process, as neededAssume the role of EDC Specialist/EDC Lead User if required Job specific competencies & skills: Comprehensive knowledge of SAS/BASE, SAS/Macro and R. knowledge of SQL, Python or other programming languages is a plusGood Knowledge of EDC (e.g Inform, Medidate Rave, Oracle RDC)Comprehensive Knowledge of CDISC in general and comprehension of SDTM and define.xmlGood Knowledge of regulations and guidance regarding clinical development, the systems used in this context and data management related aspects of e-submissionsGood team player works effectively in international teams, and multi-disciplinary groups.Excellent accuracy and attention to detailExperience in leading low to moderate complexity projects with limited support from the supervisorDatabase Developer:Comprehensive experience on database development (e.g Medrio, Inform, Medidata Rave, Oracle RDC)Comprehensive Knowledge of CDISC in general and comprehension of CDASHDepartmental Core Competencies*:Adaptability/Flexibility, Critical Thinking, Strong Communication Skill, Accuracy/Quality of Work, Analytical skills, Business Partnering, Problem Solving, Project Management and Technology Skills and Knowledge. *individual proficiency level is depending on the role/role-level We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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