• Job Description

  Req#: 279981

  Work Your Magic with us!

  Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

  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):

  Your Role:

  • 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
  • Ad hoc programming requests (e.g data format transfer and data pooling per request)

  General

  • 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
  • Works 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 initiatives
  • Develop experience and skills in new systems when necessary
  • Keep up to date with job related topics, in particular with regard to SAS, R and Spotfire and other potential language and applications

  Database 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 readiness
  • Conduct system validation as needed
  • Mentor other DBDs in all aspects of DMMI process, as needed
  • Assume 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 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 supervisor Database Developer: Comprehensive experience on database development (e.g Medrio, Inform, Medidata Rave, Oracle RDC) Comprehensive Knowledge of CDISC in general and comprehension of CDASH Departmental 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.

  What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

  Apply now and become a part of our diverse team!

• About the company

  Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.

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