Merck KGaA

Senior Specialist, Program and Application Development

Posted On

Sept. 3, 2024

Location

Mumbai, Maharashtra

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

A.Trial activities:Clinical Data Programming• 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/role• Adhoc programming requests (e.g data format transfer and data pooling per request)Operational Data Programming• Provide technical solutions to centralized monitoring activities, develop, validate and maintain the programs to identify the risk signals (e.g. key risk indicators (KRIs) for clinical data and key quality indicators (KQIs) for operational data)• Develop, validate and maintain the operational data reports (e.g. clean patient tracker (CPT), key quality indicator (KQI))Other• Communicate status and results to task owners in a timely manner• Provide relevant documentation and data for archiving• Provide programming support for strategic initiatives as assignedB. Non trial activities:• System maintenance/enhancements• Contribute to the continuous improvement, re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instructions (WIs) as needed• Contribute as team member to DMMI initiatives• Create and maintain globally re-usable SAS programs /macros that streamline repetitive operations for clinical studies• Program administrative reports as needed for clinical trials• Communicate technical programming concepts in a clear, concise and focused manner.• Develop experience and skills in new systems when necessary• Provide Training / give guidance to Clinical Data staff on the use of the applications (existing and new ones)• Keep up to date with job related topics, in particular with regard to SAS, R and Spotfire and other potential language and applications• Be up to date with SOPs, WIs, and user manuals and maintain training logSenior Specialist, Program & Application Development • Works effectively in a mixed environment and uses best practices and knowledge or even interpretation of internal and external business issues to improve products or services and to define processes and standards. • Solves high 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. • Acts as a advisor within the team regarding processes and technical solutions.Job specific Competencies & Skills• Comprehensive knowledge of SAS/BASE, SAS/Macro and R. knowledge of SQL, Python or other programming languages is a plus• Good Knowledge of EDC (e.g Inform, Medidate Rave, Oracle RDC)• Comprehensive Knowledge of CDISC in general and comprehension of SDTM and define.xml• Good Knowledge of regulations and guidance regarding clinical development, the systems used in this context and data management related aspects of e-submissions• Good team player works effectively in international teams, and multi-disciplinary groups.• Excellent accuracy and attention to detail• Experience in leading low to moderate complexity projects with limited support from the supervisorDepartmental 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 Who you are:Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences or equivalent industry experience. Proven experience (5+ years) in the area of Clinical Data Management (e.g. as Clinical Data Manager, Clinical Data Management Programmer, within Centralized Monitoring or as a Data Analyst in the pharmaceutical/biotechnology industry) 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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