Manager, clinical data manager
2 settimane fa
The Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Ensure data is managed in compliance with applicable standards (e.g., CDISC), regulatory guidelines and OPIS SOPsPrepare/validate Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.)Design/validate the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study teamPrepare/validate the e CRF/clinical databases and related toolsPrepare and manage change request of databasePerform data cleaning activitiesPerform coding activities of medications and medical terms using medical dictionariesPerform SAE reconciliation when requiredManage database lock and freeze before data analysisPrepare, maintain, and archive data management documentationPerform quality controls according to the Data Management PlanLiaise with Sponsor and external stakeholders regarding data management activitiesEscalate potential risks/issues to Direct ManagerTrack activities and milestones to ensure timely project deliverablesParticipate to meetings, kick-off meeting and teleconferences for assigned projects Organize/perform trainings for project team - Collaborate in establishing and maintaining SOPs related to Data ManagementPromote the introduction of digital technologies and innovative data processing tools and acts as a mentor for junior staffPerform and complete on time all required trainings (study trainings, training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due dateBachelor's degreeSolid knowledge of ICH-GCP/ISO14155, clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data ManagementDigital skills and good knowledge of FDA 21 CFR Part 11 and system validationSolid knowledge on relational databases and programming languagesKnowledge of SAS system is a plusExcellent knowledge about Microsoft packageStrong commitment to qualityEnglish language (fluent reading, writing and verbal skills)Planning and organizational skillsFounded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) Please read the information notice on the processing of personal data in the candidates information section of our company website.
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Manager, Clinical Data Manager
2 settimane fa
Desio, Italia OPIS A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Ensure data is managed in compliance with applicable standards (e.g., CDISC),...
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Senior Clinical Data Manager
4 settimane fa
Desio, Italia Altro A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Some of what you'll do:Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
3 settimane fa
desio, Italia OPIS A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. Some of what you'll do: Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
2 settimane fa
Desio, Italia OPIS A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. Some of what you'll do: Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
2 settimane fa
Desio, Italia OPIS A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. Some of what you'll do: Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
1 settimana fa
Desio, Italia OPIS A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Some of what you'll do:- Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
17 ore fa
Desio, Italia Opis S.R.L. A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Some of what you'll do:Ensure data is managed in compliance with applicable standards...
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Manager, clinical data manager
1 settimana fa
Desio, Italia OPIS A tempo pienoSenior Data Manager The Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. (…) Design/validate the paper and/or electronic Case Report...
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Senior Clinical Data Manager
3 settimane fa
Desio, Italia Altro A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Some of what you'll do : Ensure data is managed in compliance with applicable standards...
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Senior Clinical Data Manager
3 settimane fa
Desio, Italia Altro A tempo pienoThe Senior Data Manager reports to the Data Manager Project Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. Some of what you'll do :Ensure data is managed in compliance with applicable standards...
