Dear Members,
ATA is currently hiring a Senior Clinical Data Manager for a Global Pharmaceutical company based in Germany. The role will be based be ideal for someone who has experience leading a team or project.
Job Description:
• Preparing, conducting and closing of data management activities (e.g. design of Case Report Forms (eCRFs), patient diarys (ePRO), Data Management Plan, database structure and consistency check specifications, data review, SAE reconciliation, coding, database lock) and archiving
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Monitoring and supervision of the set-up and maintenance of CDMS systems and eTools like EDC, ePRO
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Providing input into the selection and qualification of third party vendors
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Managing and supervising Data Management CRO's or external data providers (e.g. for ePRO data , laboratory data) and performing adequate CRO/vendor oversight
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Working according to ICH-GCP and other relevant guidelines
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Ensuring that all functional activities are performed to meet the defined timelines, budget and quality specifications
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Instructing and supervising Clinical Data Coordinator and Clinical Programmer
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Providing support to the enhancement of Clinical Data Management processes and standards.
Requirements:
• You have proficiency and profound, at least 5 years experience in clinical data management in the pharmaceutical industry or CRO industry
• You have a Bachelor's degree or diploma in data sciences, natural sciences, informatics or equivalent degree
• You are an experienced user of CDMS systems and eTools like EDC, and ePRO
• You are familiar with all relevant guidelines and aspects of clinical data management
• Candidate MUST have valid EU passport or right to work in Germany to be considered for this position.
To apply for this role please contact Abhijeet Roy on [log in to unmask] or call +441753722113
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