Senior Clinical Data Management Programmer - Munich, Deutschland - Oracle
Beschreibung
Senior Clinical Data Management Programmer (M/F/d DXApplicants are required to read, write, and speak the following languages: English
Preferred Qualifications
Oracle Germany are looking for a Senior Research Management Programmer who has experience in clinical SAS programming within a CRO environment.
MISSION:
Lead the creation of and create SAS annotations and SAS specifications according to the sponsor or CDISC standard
Establish programming procedures and validation of sponsor specific SAS datasets (e.g. SDTM structure) and support less experienced team members to perform the programming in accordance with those procedures
Definition of programming and programming of status reports and listings for internal and external use, including validation steps
Coordinate the processing and administration of external data (e.g. laboratory data)
Creation and review of study specific validation procedures and testing of e.g. eCRF templates (UAT)
Participate in the creation of documents for data management (Data Management Plan, Data Management Report, Data Validation Plan) and reports, including templates review
Assistance with the design of (e)CRFs
Collaboration with statistics and EDC programming
Lead development of new and in the enhancement of existing company specific macros and tools
Initiate and coordinate data management programming procedures standardization
Consideration of the Data Management programming budget within assigned projects
Conduct quality control in order to ensure that the output meets quality standards and project requirements
Provide oversight to coordination and maintain organized, complete and up-to-date study documentation, testing and quality control documents
QUALIFICATIONS:
- University degree in Medical Documentation/Life Science/Biological Science/Informatics or a related discipline in the science/healthcare field or equivalent education
- Several years of experience in (Clinical) Data Management within a pharmaceutical company or CRO or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Programming skills in SAS, SQL and Access databases
- Knowledge and experience in CDISC SDTM desirable
- Performanceoriented, wellstructured and efficient work methods
- Ability to work both independently and efficiently within an interdisciplinary team
- Excellent planning, organisation, and communication skills
- Proficient computer skills in MS Office
- Excellent command of both written and spoken German and English
inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That's
why we're committed to creating a workplace where all kinds of people can do their best work. It's when
everyone's voice is heard and valued that we're inspired to go beyond what's been done before.
(degree of disability of at least 30% together with official decision on equality) in accordance with the German
SGB IX."
Detailed Description and Job Requirements
Responsible for conducting applied research in scientific area of focus.
Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction.
This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.
Bachelors or Advanced degree in a discipline relevant to area of focus, plus 4 year related work experienceMinimum Qualifications:
At least 6 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications
Job:
Consulting
Location:
DE-DE,Germany-MÜNCHEN
Job Type:
Regular Employee Hire
Organization:
Oracle
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