Data Coordinator and Developer (VEC)

Job Summary

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, data collection processes, and study outcomes on multiple studies as dictated by study protocols. The position coordinates the tasks performed by the data team, involves supervision of the data team, and contributes to development of procedures and tools for data team management. These studies have varying levels of complexities requiring an overall understanding of the data structures and programming. Some studies may include additional project management responsibilities at the VEC and for other stakeholders.

Organizational Status
Exercises data and project 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. Coordinates project at multi-site levels and participates in executive decision making in the project. Reports to the Senior Data Manager and Study Investigators. As the Program Manager for IMPACT (Canadian Immunization Monitoring Program, ACTive), the role also reports to the IMPACT Executive Committee.

Work Performed

Develops and oversees the required tasks from nurse monitors at 14 IMPACT Centers in regards to ongoing surveillance, new surveillance targets, and to externally funded projects. This involves helping to prepare and gather budgets, statements of work, protocols, and task authorization requests.

Provides administrative contract deliverables and monitors whether data deliverables are met across all IMPACT Centers. Completes the annual Systems Overview and Data Product Inventory for PHAC (Public Health Agency of Canada).

Organizes the annual meetings for the IMPACT Monitors and Investigators and assists with the Executive Committee and all IMPACT data working groups.

Provides information/resources for nurse monitors and other IMPACT team members. Represents IMPACT at various educational settings and provides updates on IMPACT to various groups and organizations as requested.

Creates, revises, and maintains ongoing surveillance documents such as the IMPACT directory, reporting pathway and surveillance reminders deadlines, data working group list, isolate tracking schedule lists, ICD coding list, as well as orientation and training materials.

Responsible for frequent follow-up with centers to discuss and respond to any questions, concerns, workload and priority setting. Serves as the main point of contact to coordinate internal management and/or working groups for questions. Communicates regarding isolate and specimen shipments to the National Microbiology lab. Participates in all working group teleconferences to ensure challenges are understood when discussing new and ongoing targets. Trains and orients new study monitors with support from lead scrutineer. Informs the Executive Committee of sites and monitors who are under-performing to ensure study goals are met in a timely manner.

Develops highly-specialized case report forms (CRFs) for each study. The project teams generally consist of the investigator(s), administrators, study coordinator, statistician, and data coordinator, who collectively decide what information is required for a study and how it will be collected. 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 practices 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 practices.

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.

Supervision Received
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.

Supervision Given
Supervises the data staff, a group that includes 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.

Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or the equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

University degree in Computer Science is strongly recommended with additional courses in the Health Care Field desired. Related experience in data management of clinical trials with preference for vaccine trials is required. Minimum 2 years supervisory skills.

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.