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or email your CV and cover letter to Neila Tong at Neila.Tong@bcchr.ca
M&P - AAPS
AAPS Salaried - Information Systems and Technology, Level B
Data Coordinator & Developer
Vaccine Evaluation Centre | Department of Paediatrics | Faculty of Medicine
$5,468.83 - $7,878.17 CAD Monthly
Posting End Date
August 12, 2021
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
This offer is conditional upon successful completion of a Criminal Record Check.
This individual is a member of the Vaccine Evaluation Center (VEC) whose primary role is to provide consultation to Investigators in the identification of data, and on data collection processes and study outcome on multiple studies as dictated by study protocols. The position coordinates the tasks performed by the data team and involves supervision of the data team. These studies have varying levels of complexities requiring an overall understanding of the data structures and programming.
Exercises data management judgement (including non-routine) and is accountable for own directed actions. Makes judgements as to how the decision fits with acceptable Good Clinical Data Management Practices and what the impact of the decision will be. Reports to Senior Data Manager of the VEC.
Development of highly-specialized case report forms (CRFs) for each study. The project team consists of the investigator(s), field administrators, study coordinator, statistician and data coordinator who decide what information is required for a study and how it will be collected. Using this information, the data coordinator will formulate the CRF that will encompass all the needs of the study and maintain good clinical data management practise guidelines. The investigator(s) have final approval of the CRFs. Each study is faced with unique issues and the data coordinator must research and evaluate appropriate uses of data collection tools, usage of words in questions and style of questions. The data coordinator is continually evaluating the CRFs and accompanying user’s manual to ensure that the best possible tools are provided for the study.
The data coordinator is responsible for designing and implementing systems for organizing and managing the flow of data from the field through data management to analysis and to long term storage. This requires good organizational skills as there can be 15-20 different studies in progress and at different stages. In addition, data is received from many different sites across Canada in multi-centre clinical trials, which adds to the complexity of the job. This individual supervises the work of the data entry and data monitoring staff. This involves training and monitoring staff, reviewing workload assignments and adjusting schedules to reflect changes and priorities within the VEC.
The data coordinator manages the data throughout the course of each study ensuring that all work performed by study staff adheres to policies and standards. The data coordinator is responsible for maintenance of the database until study completion. Upon meeting all requirements for clean data, the database is given to the Statistician. Each study and sponsor have different needs making each study unique. The individual must be adaptable to the needs of each study to ensure good clinical data management practises are maintained.
Databases (both routine and complex) are custom designed and maintained by the data coordinator. This requires an in-depth working knowledge of software being used and keeping abreast of software changes as they occur. Maintaining and upgrading of the databases forms part of the duties.
Works in conjunction with the statistician to develop descriptive aggregate statistics for data cleanup and ensure that final statistical programme incorporates data management decisions during the study.
When necessary, provides basic statistical programming support as per pre-defined analysis plan.
The data coordinator is responsible for the long-term storage of VEC data that conforms to government set standards. The data coordinator needs to keep up with changes in the technology and acceptable practises.
Consequence of Error/Judgement
Errors in judgement can result in significant damage to the Vaccine Evaluation Center’s academic reputation as a centre of excellence, nationally and internationally. Poorly designed databases can result in higher study costs because of extra time spent dealing with data entry, data management and data analysis. Poorly designed databases can also result in making it difficult to perform effective data analysis affecting the overall science of the study. Ineffective training of data staff has budgetary and human resource implications. The systems to organize and manage the flow of data that are not appropriately designed can lead to financial problems as well as problems with conforming to good clinical data management guidelines.
Receives general directions from project team leader(s) and the investigator(s) as part of the specified project team for study related issues. Study related work is reviewed by the Senior Data Manager.
Supervises the data staff, a group that includes up to 8 research assistants and data monitoring staff. This includes assigning and monitoring the work, training staff and participating in job evaluation/performance measures. Works with the statistician to coordinate the flow and priority setting of the data and the analysis. Works with the field administrator(s) to ensure the efficient flow of data from the field to the data team and to coordinate workload of research assistant staff.
Undergraduate degree in a relevant discipline. University degree in Computer Science is strongly recommended with additional courses in the Health Care Field desired. Minimum of five years experience or the equivalent combination of education and experience. Minimum of three years of related experience in data management of clinical trials with preference for vaccine trials. Minimum 2 years supervisory skills.
Demonstrated knowledge of web-based clinical data management software. Experience in SAS® statistical software is required. Ability to perform advanced programming. Demonstrated information management skills are required. Ability to communicate effectively verbally and in writing. Proven problem solving, analytical and decision making skills. Ability to maintain accuracy and attention to detail. Ability to work effectively independently and in a team environment. Ability to work under pressure to meet deadlines and to set priorities for concurrent projects.