Clinical Data Manager - Germany

My client is an innovative pharmaceutical company specialising in developing first class products for a diverse range of unmet medical needs. A vacancy has arisen for a Clinical Data Manager for their European headquarters in Germany.
Job Description:
Managing international and local studies in the area of ​​Data Management 
Coordination and management of all relevant project plans for the efficient and timely delivery of all target data with internal and external partners
Development of Metric reports to evaluate the project progress 
Central point of contact in all aspects of data management and related cooperation with other internal project groups 
Working with CROs and external customers
Our requirements:
BSc or MSc in a Science related subject
A minimum of 5 years experience in the pharmaceutical industry working in Clinical Data Management

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Senior Statistician - Germany

My Client is a leading full service Clinical Research Organisation who are looking for a Senior Statistician with experience of using SAS to join their Biometrics team. 
• To support the generation and review of the procedures, guidelines, manuals or other documents applicable to the general or project-related biostatistical activities of Biostatistics & Programming (BS). Specifically, to generate and review Statistical Analysis Plans for clinical trial projects and to generate, validate and run SAS programs as required within the statistical analysis process.
• To prepare statistical or integrated study reports as required by contracts and to take responsibility for the correct interpretation of the results within the report.
• To provide biostatistical information and assistance within the company. This includes to support the DBPEU/MBP in the generation of budget proposals for biostatistical activities. Upon previous authorisation of the supervisor and if required by the sponsor, to contact external parties with respect to biostatistical activities.
• To supervise and instruct the department’s personnel concerning biostatistical activities of projects. If required, to prepare, conduct or assist in general and in project-related biostatistical training. Additionally, to prepare, conduct or assist in training sessions regarding biostatistical topics for sponsors or other company departments.
• To participate and support the organisation of department, group or project-related meetings. This includes to support, provide information, and participate in discussions during audits and inspections which include biostatistical activities. Additionally, to participate and represent the department in meetings and other events at sponsor’s and authorities locations, research institutions and other organisations in the scope of the company, department and/or project-related activities. 
• To assist the DBPEU/MBP in the evaluation of the group’s workload, cost and manpower.
• To report to the DBPEU/MBP on the biostatistical activities and/or project status.
• To adhere to the regulatory requirements, to the ICH-GCP guidelines and  to the respective procedures (policies, SOPs, instructions) of the company or if required of the sponsor
• To supervise the adherence to the regulatory requirements, ICH guidelines, company’s, and if required, sponsor’s procedures and to conduct training of applicable procedures.
Requirements:
• Experience of at least 5 years in the area of statistical programming, either at university, or preferably in the pharmaceutical industry or in a CRO



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