Clinical Data Associate
7 days ago
Base level rolePerform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.Perform ongoing Data Reconciliation of all data streamsAttend study related meetings/teleconferencesPerform Study Closeout/Archiving Activities including QC of subject/site Archival CRFsCreate and provide status/metric reportsGenerate reports on EDC and track cleaning progressManage Freeze / lock of eCRFFile documentation in the virtual Trial Master File (TMF)Receives and enters lab normal rangesAdvance level roleProvide timely status updates including issues & risks to DM and DMLs as neededAct as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigationsMay communicate with the vendors to resolve reconciliation issues.Provide input to Study set up activities including but not limited to creation of DVRsCreate and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.Assist the Data Management Leader in TMF compliance reviews.Train and mentor CDA staffMay serve as an SME and participate in SME forumsMay act as delegate for Data Manager, as neededEducation and Experience Guidelines:Bachelor's degree in a Health or Science discipline with experience in clinical research.Data Management experience and experience working on a clinical trial mandatory.Rave experience mandatoryExperience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.Knowledge of technology platforms and systems to capture and process dataProject management skills.Vendor management skills.Proficiency with Microsoft Office toolsExperience CDA BASE level: 1-3 years of experience.Experience CDA ADVANCED level: >3 year of experienceIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more
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Clinical Data Manager
1 week ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R1 200 000 - R2 400 000 per yearLooking for data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS)Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when...
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Clinical Data Manager
1 week ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R1 200 000 - R1 800 000 per yearLooking for data management expert, who has prior experience in performing scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS)Prior experience of closely collaborating with the SRP, SRS, Data Management functions and the rest of the study team members when...
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Clinical Data Specialist
1 week ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R150 000 - R250 000 per yearPURPOSE Provide basic and some comprehensive data management expertise to the Clinical Data Management team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator, Data Team Lead, or Functional...
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Clinical Project Coordinator, Biotech
7 days ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R900 000 - R1 200 000 per yearJob OverviewIQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.The Clinical Project...
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Project Data Manager
5 days ago
Bloemfontein, Orange Free State, South Africa Syneos Health Careers Full time R250 000 - R750 000 per yearProject Data Manager (Romania, Poland, Hungary, Slovakia, South Africa Only)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings...
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Associate Quality Review Specialist
5 days ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R150 000 - R250 000 per yearRESPONSIBILITIESConduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations. Ensure that re-occurring findings/errors are communicated effectively with operational team. Participate in review of corrective/preventative actions. Assure recording of an appropriate response...
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Associate Quality Review Specialist
1 week ago
Bloemfontein, Orange Free State, South Africa IQVIA Full time R900 000 - R1 200 000 per yearRESPONSIBILITIES Conduct internal Data Management Quality Reviews in order to fulfil business unit, customer and regulatory authority requirements and expectations. Ensure that re-occurring findings/errors are communicated effectively with operational team. Participate in review of corrective/preventative actions. Assure recording of an appropriate response...
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Bioanalyst
2 weeks ago
Bloemfontein, Orange Free State, South Africa FARMOVS Full time R250 000 - R450 000 per yearAbout UsAre you ready to be part of a pioneering force in clinical research? With a rich history dating back to 1974, FARMOVS has been at the forefront of accelerating product development through innovative ICH GCP compliant phase 1-2a clinical trials. Having conducted over 3000 trials at our esteemed facility, we offer unmatched expertise and experience in...
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Senior Statistical Programmer
1 week ago
Bloemfontein, Orange Free State, South Africa MMS Holdings Inc. Full time R90 000 - R120 000 per yearAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention...
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Project Quality Lead I
4 days ago
Bloemfontein, Orange Free State, South Africa FARMOVS Full time R250 000 - R500 000 per yearAbout Us:Are you ready to be part of a pioneering force in clinical research? With a rich history dating back to 1974, FARMOVS has been at the forefront of accelerating product development through innovative ICH GCP compliant phase 1-2a clinical trials. Having conducted over 3000 trials at our esteemed facility, we offer unmatched expertise and experience...
