Języki
angielski
dobry
niemiecki
podstawowy
Doświadczenie zawodowe
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Clinical Data Manager/Line manager
Performing all tasks relating to data management from the start to the finish of a study:
• defining Database Build specification and test database;
• assisting in the testing of databases prior to activation;
• creating study specific documentation;
• assisting with the processing of clinical data for projects;
• supervising the study specific Data Entry Team;
• critically review CRFs as specified in the study specific DMP and to query and resolve any errors/quires as required;
• assisting with the coding of adverse events, medical history and medications;
• performing SAE reconciliation for EDC study
• performing the Quality Control of Data Entry;
• preparing any documentation for return at study completion;
• reporting study progress against schedules to management and client
• defining Database Build specification and test database;
• assisting in the testing of databases prior to activation;
• creating study specific documentation;
• assisting with the processing of clinical data for projects;
• supervising the study specific Data Entry Team;
• critically review CRFs as specified in the study specific DMP and to query and resolve any errors/quires as required;
• assisting with the coding of adverse events, medical history and medications;
• performing SAE reconciliation for EDC study
• performing the Quality Control of Data Entry;
• preparing any documentation for return at study completion;
• reporting study progress against schedules to management and client
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Clinical Data Coordinator + Line Manager
Study Base Set Up
• To assist in the database construction and testing thereof
• To assist in the preparation of study specific documentation as appropriate
Management of CRFs for allocated projects
• To assist in the management of tracking and log-in of CRFs
• To maintain a stable electronic CRF management system. Receive CRFs and record their movement in an electronic CRF management system.
• To enter/edit data from CRFs into the study database.
• Archiving CRFs/Transit of CRF for translation/ back to clients.
Review of CRFs for allocated projects
• To resolve Self-Evident Queries/Allowable Changes in the study specific Database
• To track and resolve Data Clarification Forms in the study specific Database
• To assist with the Quality Control of Data Entry and CRF/database as appropriate
• To assist study specific Lead Data Managers preparation of status report for clients
To perform other reasonable tasks as requested by management
• To assist in the database construction and testing thereof
• To assist in the preparation of study specific documentation as appropriate
Management of CRFs for allocated projects
• To assist in the management of tracking and log-in of CRFs
• To maintain a stable electronic CRF management system. Receive CRFs and record their movement in an electronic CRF management system.
• To enter/edit data from CRFs into the study database.
• Archiving CRFs/Transit of CRF for translation/ back to clients.
Review of CRFs for allocated projects
• To resolve Self-Evident Queries/Allowable Changes in the study specific Database
• To track and resolve Data Clarification Forms in the study specific Database
• To assist with the Quality Control of Data Entry and CRF/database as appropriate
• To assist study specific Lead Data Managers preparation of status report for clients
To perform other reasonable tasks as requested by management
Szkolenia i kursy
Project Management according to PMI standards
Human Resource Management and Team Building
Human Resource Management and Team Building
Edukacja
Inne
Project Experience:
• Non-interventional
• GCP
• Clinical Trials
• Studies range from Phase I to Phase IV
Therapeutics Areas:
• Oncology
• Ophthalmology
• CNS
• Cardiovascular
• Metabolism
• Infectious Diseases
• Pain
Technical Experience:
• Oracle Clinical
• Study Builder
• MS Office
• Eclipse
• PPMS
• E-Trials
• ClinNav
• driving licence, cat. "B"
• I am a good team player
• Non-interventional
• GCP
• Clinical Trials
• Studies range from Phase I to Phase IV
Therapeutics Areas:
• Oncology
• Ophthalmology
• CNS
• Cardiovascular
• Metabolism
• Infectious Diseases
• Pain
Technical Experience:
• Oracle Clinical
• Study Builder
• MS Office
• Eclipse
• PPMS
• E-Trials
• ClinNav
• driving licence, cat. "B"
• I am a good team player
Grupy
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Marketing Sekrety. Social Media Marketing. Marketing wirusowy, marketing szeptany, event marketing, experiential marketing, guerilla marketing, marketing doświadczeń, content marketing.
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Pharma Market
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