KLIFO is looking for a talented and committed Data Manager/Programmer Clinical Trials
KLIFO A/S is expanding and just established its first subsidiary outside Denmark in Munich, Germany. KLIFO GmbH now wants to appoint a Data Manager/ Programmer for clinical trials into a dynamic and experienced team within Clinical Operations Solutions in either its office in Munich or near Copenhagen (Denmark). The people we want to engage have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.
KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.
The position as Data Manager/Programmer within Clinical Operations Solutions:
Responsibilities of the Data Manager/Programmer include:
- Cooperate closely with biostatisticians, medical reviewers and project managers
- Database set-up and testing, usually within an eCRF system
- Set-up and testing of online edit checks
- Program (within the eCRF system or in SAS®) various listings, overviews and summary tables for medical reviewer, status reports, project management; provide updated outputs on a regular basis
- Support programming (in SAS®) of data listings for clinical study reports
- Perform quality control of programs
- Writing or peer review of Data Management Plans and Data Validation Plans
- Continuous data cleaning, data base lock
- Support maintenance and further development of internal standards and of Standard Operating ProceduresContribute to harmonization of data management processes between KLIFO offices.
The qualifications of the Data Manager/Programmer:
The Data Manager/Programmer should possess the following qualifications and skills:
- Professional data management experience in the pharmaceutical or biotech industry, in a CRO or in an academic environment
- Experience with the use of eCRF systems to set up eCRFs and online checks and to perform continuous data management activities
- Very good SAS® programming skills are important
- Familiarity with CDISC standards
- Knowledge of relevant regulatory guidelines • Analytical thinking, familiarity with medical terminology
- Quality orientation, efficiency, and reliability
- Customer orientation and flexibility
- Willingness to travel occasionally
- Fluent in English (spoken and written), and in either German or Danish.
In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.
- Work within different therapeutic areas and with tasks of varying complexity
- Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
- Use - and elaborate - your competences and experience
- A team of experienced colleagues
- Work in a European-based company with global reach
- Work in an interactive, flexible and positive working environment.
As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO A/S can be found at www.klifo.com.
Applications including salary expectations should be sent to: email@example.com, marked “Data Manager/Programmer”