Luhandri van Zyl
Associate Manager at MMS- Claim this Profile
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Bio
Experience
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MMS
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United States
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Pharmaceutical Manufacturing
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400 - 500 Employee
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Associate Manager
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Jul 2022 - Present
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Senior Data Team Lead
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Jul 2021 - Jun 2022
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Data Team Lead
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Nov 2020 - Jul 2021
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Data Team Lead
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Sep 2019 - Nov 2020
Key Responsibilities:*Lead negotiations with customers, participates in pricing discussions and supports the Request for Proposal (RFP) process.*Manage Scope of Work (SOW) and/or budget, ensuring that services are met according to the SOW/contract.*Serve as point of contact for customers on data management deliverables, ensuring open communications with the customer and management to meet contractual obligations.*Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.*Meet with Data Operations team members to ensure milestones meet timelines and quality deliverables.*Manage process improvements and workload projections.*Manage DM service delivery with comprehensive DM process and technical expertise.*Create and/or review and sign-off on all data management plan (DMP) documents.*Ensures service and quality meet agreed upon specifications per the DMP and contract/SOW.*Ensure appropriate resources are assigned to meet project deliverables.*Implement quality management plans.*Provide training and development and data management expertise to DM team members.*Train, mentor and provide leadership to the DTL team.*Ensure project milestones are met according to agreed upon timelines.*Serve as the escalation point for unresolved data issues working with client data managers, vendors, internal team members for resolution.*Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.*Ensure timely follow-up and resolution of issues.*Escalate problems/issues to the attention of the Project Manager and Line Manager. Show less
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Associate Clinical Data Manager/Validation Team Lead
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Jan 2016 - Aug 2019
Key Responsibilities:*Manage communication, planning and risk management related tovalidation activities with Data Team Lead, Clinical Database Programmer and Validation Analyst (VA) during the validation process of database programming related activities.*Manage delivery of the project during the validation process.*Ensure project milestones are met according to agreed upon timelines.*Escalate problems/issues to the attention of the Data Operations Coordinator, Data Team Lead or Line Manager.*Comply with the core operating procedures and working instructions.*Maintain good communications and working relationships within the DM team. Show less
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Clindata
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South Africa
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Associate Biostatistician
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Jan 2015 - Dec 2015
Provide statistical support for the production and checking of statistical outputs and the development of analysis plans. Assist in trial design tasks and Data Management consultation. Read/write/understand protocols. Analyses and interpretation of data Programming datasets using SAS Provide statistical support for the production and checking of statistical outputs and the development of analysis plans. Assist in trial design tasks and Data Management consultation. Read/write/understand protocols. Analyses and interpretation of data Programming datasets using SAS
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Associate Clinical Data Manager/Validation Team Lead
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Jul 2012 - Dec 2014
Key Responsibilities:*Manage communication, planning and risk management related tovalidation activities with Data Team Lead, Clinical Database Programmer and Validation Analyst (VA) during the validation process of database programming related activities.*Manage delivery of the project during the validation process.*Ensure project milestones are met according to agreed upon timelines.*Escalate problems/issues to the attention of the Data Operations Coordinator, Data Team Lead or Line Manager.*Comply with the core operating procedures and working instructions.*Maintain good communications and working relationships within the DM team. Show less
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Clinical Data Coordinato/Data Operations Coordinator
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Jan 2010 - Jun 2012
Key Responsibilities:•Serve as a Data Operations Coordinator (DOC) for one protocol with lessthan 5 operations staff (excludes DE) or a leadership role in a specific area orprocess on a large study with guidance.•Serve in the role of back-up to a DOC or Data Team Lead.•Conduct data review.•Write and resolve data clarifications.•Lead database audit team.•Develop and test databases and edit specifications
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Education
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University of the Free State
BSc Hons., Statistics -
University of the Free State
Bachelor's degree, Chemistry and Statistics