Jaco Dreyer Email and Phone Number

• Plan Project execution with the insight of Research Data Management (RDM)• Assist Study Coordinators with project management of operational tasks as it relates to (RDM)• Setup Data Collection Forms utilizing REDCap• Setup Pentaho transformation to manage the movement of data between different REDCap projects, MySQL and MS SQL databases• Import and reconciliation of Electronic data, for example Lab data and resolve queries with the Lab• Setup Reports, Metrics, Dashboards… Show more • Plan Project execution with the insight of Research Data Management (RDM)• Assist Study Coordinators with project management of operational tasks as it relates to (RDM)• Setup Data Collection Forms utilizing REDCap• Setup Pentaho transformation to manage the movement of data between different REDCap projects, MySQL and MS SQL databases• Import and reconciliation of Electronic data, for example Lab data and resolve queries with the Lab• Setup Reports, Metrics, Dashboards and Progress Tracking information• Create the extraction of datasets from databases and related research databases for statistical analysis purposes utilizing Pentaho• Stewardship and curation of all trial data for assigned projects in accordance with the AHRI’s data access policy• Setup systems and procedures to assess and assure the quality of research data in assigned projects• Mentoring and training of junior staff Show less

The purpose of the TasP Research Data Manager is to maximize access by Africa Centre scientists particularly for TasP project to high quality research data pertaining to the TasP trial.DUTIES AND RESPONSIBILITIES RELATED TO KEY RESPONSIBILITY AREAS (KRA)If one of the KRAs includes financial responsibilities, then explain the nature and extent below.1. Stewardship and curation of all TasP trial data in accordance with the Africa Centre’s data access policy2. Prepare or arrange… Show more The purpose of the TasP Research Data Manager is to maximize access by Africa Centre scientists particularly for TasP project to high quality research data pertaining to the TasP trial.DUTIES AND RESPONSIBILITIES RELATED TO KEY RESPONSIBILITY AREAS (KRA)If one of the KRAs includes financial responsibilities, then explain the nature and extent below.1. Stewardship and curation of all TasP trial data in accordance with the Africa Centre’s data access policy2. Prepare or arrange for the extraction of datasets from the ACDIS and TasP databases and related research databases for statistical analysis purposes3. Assess and assure the quality of research data in the TasP trial4. Assist the TasP project management with operational tasks as it relates to research data management Show less

• Perform QuIPS support to QA team including QuIPS training for new QA staff; refresher training and work with the system developers to address technical issues• Provide input into the development of QuIPS as used by QA for GxP audits and for the processing of data from sponsor audits and regulatory inspections• Support QA Management with the input of data into Project View, provide training and guidance on the system and assist in the development of the system to meet QA… Show more • Perform QuIPS support to QA team including QuIPS training for new QA staff; refresher training and work with the system developers to address technical issues• Provide input into the development of QuIPS as used by QA for GxP audits and for the processing of data from sponsor audits and regulatory inspections• Support QA Management with the input of data into Project View, provide training and guidance on the system and assist in the development of the system to meet QA needs• Produce TIME reports and metrics for QA• Liaise with the Regulatory and Quality Intelligence (RQI) team regarding the development and validation of QA audit metrics• Liaise with Information Technology for the update and maintenance of the QA Sharepoint site• Explore the further use of technologies by QA and support the QA team in associated metrics data interpretation and application• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Show less

The Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, PAREXEL procedures and appropriate PAREXEL processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Assist with the training of less experienced auditors and in the provision of direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance, with… Show more The Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, PAREXEL procedures and appropriate PAREXEL processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Assist with the training of less experienced auditors and in the provision of direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance, with appropriate supervision. Show less

Managed a group of 16 people that included Clinical Data Manager, CRF Designer and Data Entry Specialists. Planned resources, workout timelines, problem solving, implementing new initiatives, attend sponsor meeting, day-to-day staff management.

Trained to created SAS programs for generating tables, listings and figures.

• Review the respective study protocol/CRF• Establish timelines with Project Managers and Sponsor • Preparation of DVS and DMP and other study relevant Data Management Documents• Adherence to agreed timelines• Development of study databases including data-entry screens• Test Data Entry and Data Check for Clinical Trials• Development of validation programs• Development of data load programs and data conversion programs• Development of subject data listings and… Show more • Review the respective study protocol/CRF• Establish timelines with Project Managers and Sponsor • Preparation of DVS and DMP and other study relevant Data Management Documents• Adherence to agreed timelines• Development of study databases including data-entry screens• Test Data Entry and Data Check for Clinical Trials• Development of validation programs• Development of data load programs and data conversion programs• Development of subject data listings and status reports• Contribute to the Quality of Data Management• Contribute File Transfer for Clinical Data• Maintain good relations with external and internal clients• Management and further development of existing data management software tools• Actively mentor Associate Clinical Data Manager and Clinical Data Manager for specific projects• Ensure that new personnel and especially temporary help and freelancers know the SOPs• Participate in trainings and continue to learn and to implement new data entry and data transfer methods used in all business areas of PAREXEL • Organization of availability of DE persons and fulfilling of double data entry requirements• Prepare and conduct trainings in known systems for Data Management Show less

• Deliver best value and high quality service for the benefit of the Clinical Data Manager through the application of technical programs or database implementation. • Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Guidelines, appropriate regulations and Computer System Validation (CSV) requirements.• Maintain all supporting documentation in… Show more • Deliver best value and high quality service for the benefit of the Clinical Data Manager through the application of technical programs or database implementation. • Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Guidelines, appropriate regulations and Computer System Validation (CSV) requirements.• Maintain all supporting documentation in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance. Document any deviations and disseminate to the rest of the group.• Provide local or global support/mentoring to Data Management on technical activities. • Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.• Participate in the rollout of Process and Systems as part of the project implementation teams, when required.• Participate in internal/external audits and regulatory inspections as required. • Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other applicable local and international regulations.• Works closely with IS, QMG and other DM operations staff to ensure continuous process improvement.• Provide relevant training for staff and project teams to assist them in resolution of problems encountered in the conduct of their daily work or on application of Clinical Systems. • Provide input into other Technical Operations Group activities as required or reasonably requested.• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.• Maintain technical documentation - parts that are applicable to the Technical Operation Group. Show less

• Setting up Timeslicing.• Create or modify, program, test and document basic checks. (Tweaking existing checks, writing new simple checks as needed).• Provide input to the SI (System Independent) dataset specifications.• Write programs necessary to combine data from various sources to support data integration.• Design, program, test & document more complex checks (e.g. SAS & SQL checks).• Map source data to SI dataset items utilising the specified tool (e.g… Show more • Setting up Timeslicing.• Create or modify, program, test and document basic checks. (Tweaking existing checks, writing new simple checks as needed).• Provide input to the SI (System Independent) dataset specifications.• Write programs necessary to combine data from various sources to support data integration.• Design, program, test & document more complex checks (e.g. SAS & SQL checks).• Map source data to SI dataset items utilising the specified tool (e.g. InView).• Execute unit testing of mapping.• UAT of new tools.• Approve and accept the implementation of the study specification. For example, (a) approve and accept the eCRF after providing the SI dataset spec and DVS and/or (b) review and agree that external data is being provided per SI dataset specification.• Ensure timely data integration of eCRF and non eCRF data is completed using appropriate resource/skill sets.• Work with Statistics, Clinical and Regulatory to identify submission needs. Show less

• Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s).• Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects. • Business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes.• Respond to Health Authority requests for data management… Show more • Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s).• Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects. • Business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes.• Respond to Health Authority requests for data management issues.• Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned projects(s).• Provide input, review and maintenance of global working practices and standards.• Contribute to the development of the Data Management organization through his/her leadership role within the DM Group.• Track and report status and progress if data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases. Ensure appropriate Novartis tracking systems are up to date and accurate.• Lead and support clinical & non-clinical special projects.• May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff. Show less

• Supervise a team of Data Managers, Data Administrators, and Data Capturers.• Develop and implement research databases in environments such as DataFax, MS Access, MS Excel, and SQL Server.• Review research protocols in order to design case report forms, source documentation, and data entry screens.• Supervise pilot-testing of case report forms.• Develop and implement database validation testing algorithms.• Develop edit checks for all study databases.• Develop and… Show more • Supervise a team of Data Managers, Data Administrators, and Data Capturers.• Develop and implement research databases in environments such as DataFax, MS Access, MS Excel, and SQL Server.• Review research protocols in order to design case report forms, source documentation, and data entry screens.• Supervise pilot-testing of case report forms.• Develop and implement database validation testing algorithms.• Develop edit checks for all study databases.• Develop and implement quality management systems.• Oversee data management documentation.• Maintain safe and secure storage of all electronic data and case report forms.• Assist the CIO in the development and implementation of employee training.• Assist the CIO in the development and implementation of departmental systems and structures, including: forms and reports templates, documentation standards, standard operating procedures, and work practice guidelines.• Ensure that good clinical practice guidelines are followed. • Communicate with representatives from sponsoring company as necessary. Show less

• Manage a team of professional Data Management staff- Size of team could very from 4 upwards, depending on the Data Management function (it averaged at 12).• Define resource requirements and work with line manager to provide resource assignments across projects. • Provide review and guidance for production of Data Management documentation or deliverables that are produced by the Data Management function. • Provide technical advice and solutions with internal an external… Show more • Manage a team of professional Data Management staff- Size of team could very from 4 upwards, depending on the Data Management function (it averaged at 12).• Define resource requirements and work with line manager to provide resource assignments across projects. • Provide review and guidance for production of Data Management documentation or deliverables that are produced by the Data Management function. • Provide technical advice and solutions with internal an external customers to solve problems and improve efficiency. • Primary customer interactions at project level with a focus on specific Data Management function. • Ensure project milestones pertaining to Data Management function are met according to agreed upon timelines with high quality. Show less

• May serve as Lead Programmer on the corporate team. • Plan and coordinate database design, development, implementation, maintenance and user support of clinical systems. • Provide technical expertise in conjunction with internal and external clients. • Program, test and document databases in accordance with programming standards and validation procedures. • Program database manipulation and transfers of data for internal and external clients. • Mentor other… Show more • May serve as Lead Programmer on the corporate team. • Plan and coordinate database design, development, implementation, maintenance and user support of clinical systems. • Provide technical expertise in conjunction with internal and external clients. • Program, test and document databases in accordance with programming standards and validation procedures. • Program database manipulation and transfers of data for internal and external clients. • Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.• Independently bring project solutions to the CDP teams and the Clinical Data Programming department. • May assist in developing and implementing new technologies. • May assist IT in testing and evaluating new upgrades to technologies Show less

• May serve as Lead Programmer on the corporate team. • Assist in planning and coordinating database design, development, implementation, maintenance and user support of clinical systems.• Assist with the programming, testing and documenting databases in accordance with the programming standards and validation procedures. • Assist with the programming database manipulation and transfers of data for internal and external clients. • May assist in developing and implementing… Show more • May serve as Lead Programmer on the corporate team. • Assist in planning and coordinating database design, development, implementation, maintenance and user support of clinical systems.• Assist with the programming, testing and documenting databases in accordance with the programming standards and validation procedures. • Assist with the programming database manipulation and transfers of data for internal and external clients. • May assist in developing and implementing new technologies. • May assist IT in testing and evaluating new upgrades to technologies. Show less