Closing Date: 13 Mar 17
Salary (£): 60,000 - 80,000
Implementation of Data management activities within assigned clinical trials. Preparing, conducting and closing of data management activities (e.g. design of Case Report Forms (eCRFs), patient diaries (ePRO), Data Management Plan, database structure and consistency check specifications, data review, SAE reconciliation, coding, database lock) in cooperation with Data Management CRO's.
Our client is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. They are an entrepreneurial specialist delivering true benefits to patients. This distinguishes them from others. By sustainably investing in research and development above the industrial average, they are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Our client is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.
Currently our client is looking for a
Senior Clinical Data Manager (m/f)
Location: Aachen (Germany)
• Implementation of Data management activities within assigned clinical trials
• Providing input into the selection and qualification of third party vendors.
• Preparing, conducting and closing of data management activities (e.g. design of Case Report Forms (eCRFs), patient diaries (ePRO), Data Management Plan, database structure and consistency check specifications, data review, SAE reconciliation, coding, database lock) in cooperation with Data Management CRO's
• Define (quality) requirements for activities performed by Data Management CRO's or external data providers (e.g. for ePRO data, laboratory data) and provide adequate sponsor oversight
• Creation and execution of data quality checks
• Monitoring and supervision of the set-up and maintenance of CDMS systems and eTools like EDC, ePRO
• Filing and archiving of trial documentation
• Ensuring that all functional activities are performed to meet the defined timelines, budget and quality specifications
• Ensuring compliance according to GCP-ICH and other relevant guidelines
• Support of the creation, review and approval of procedural documents for the Clinical Data Management area
• Contribution to the further development of the Data Management department
• Bachelor’s degree or diploma in data sciences, natural sciences, informatics or equivalent degree
• Proficiency and profound experience in all relevant clinical data management activities in the pharmaceutical industry or CRO industry
• Experience in leading CDM activities on trial level and managing and supervising external CROs / vendors
• Experienced user of CDMS systems and eTools like EDC (Medidata Rave) and ePRO
• Strong understanding of data and database structures (CDISC SDTM)
• Experience in working with SAS and J-Review
• Proven ability to work in cross functional teams
• Being familiar with all relevant guidelines and aspects of clinical data management
• Pro-active and self-motivated personality and flexible but persistent and result-oriented
• Excellent communication skills
• Proficient verbal and written skills in English
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