Job Description

DescriptionThis position is a part of the Non-Academic Staff Association (NASA).This position offers a comprehensive benefits package which can be viewed at: .Location - This role is hybrid with a mix of remote and in-person.Working at the University of AlbertaThe University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Mxc3xa9tis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community.The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.Your work will have a meaningful influence on a fascinating cross-section of people - from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. .Working for the Canadian VIGOUR CentreThe Canadian VIGOUR Centre (CVC) is an Academic Research Organization (ARO) committed to enhancing cardiovascular health. Our centre provides leadership in clinical trials of cardiovascular therapies from study design to manuscript publication, developing selected registries, and informing clinical practice through insights gained from population health data. The CVC is anchored by a dedicated group of internationally recognized thought leaders in cardiovascular medicine and clinical investigation and supported by accomplished administrative and clinical operations teams and experienced biostatisticians, data analysts, and ECG Core Laboratory personnel.PositionThe Data Management Coordinator will be responsible for leading all clinical trial data management activities in accordance with Good Clinical Practices, regulatory requirements and applicable legislation and privacy. This position will be a primary point of contact for projects involving data management at the Canadian VIGOUR Centre (CVC) and work closely with the investigator, sponsor and clinical trials team to execute the development, build, testing and validation of clinical trial and other databases, as well as the creation of supporting manuals and procedural plans which meet regulatory requirements.DutiesProject Management

• Reviews new clinical study (including industry, investigator-initiated, pragmatic clinical trials and other) requests, liaises with requestors to assess project timelines for database build, coding, management, data linkages and feasibility, and develops a plan for completion of work in collaboration with the team.
• Assists in the development of cost estimates for proposals, ensuring alignment with clinical study timelines/expectations and resourcing.
• Maintains systems and tracking for reporting on clinical study-related activities for billing and cost recovery
• Oversees all clinical study-specific clinical data management activities in accordance with Good Clinical Practice (GCP), regulatory requirements, and other relevant standard operating procedures and guidelines.

• Work closely with faculty, project lead and senior biostatistician through the lifecycle of a clinical study from protocol development through final reporting, ensuring deliverables are of high quality and documented.
• Create and review clinical data management deliverables, including data collection forms, electronic case report forms, data integrity checks, database/management manuals and procedures and data collection guidelines.
• Create, implement and review standard operating procedures (SOPs), ensuring SOPs are complied and updated for all data management activities and align with regulatory requirements.
• Represent the functional group for all related audits and inspections; review audit reports; ensure corrective action plans are responded to and/or implemented in a timely manner.
• Develop, test and implement innovative clinical data management and reporting solutions to support the needs of the projects and stakeholder requirements. Further develop and/or source systems/solutions to support varying needs and requirements on projects.
• Build strong and productive relationships and represent CVC as the primary point of contact for data management with study sponsors, clinical investigators and internal project team, business office and faculty as required locally, provincially, nationally, and internationally.
• Where appropriate drafts/supports and prepares ethics applications, reviews and standards, and ensures that research programs/activities and data acquisitions are aligned with ethics.

Administrative

• Promotes compliance by monitoring the progress and performance of assigned operational projects on an ongoing basis and ensuring that services performed adhere to regulatory requirements and quality standards, in accordance with agreed-upon timelines, and within budgetary limits
• Develop appropriate operational and data management plans including workflow, documentation, quality control, roles and responsibilities and timelines.
• Develop and implement processes to maximize standardization and achieve optimal efficiency.
• Identify and resolve operational problems, issues, obstacles and barriers based on metrics, data, audit reports, and input from groups involved in the clinical study.

Technical

• Oversee, implement and document testing, validation and maintenance of electronic data capture (EDC) systems, such as REDCap, utilized on CVC clinical studies.

• Ensure compliance related to regulatory and SOPs; develop and maintain supporting documentation for all EDCs
• Use expert knowledge to keep abreast of current industry developments and standards; work collaboratively with clinical research teams internally and externally to assess new EDC products/features based on project/study requirements.
• Work with product vendors to maintain good working relationships, provide input on functional requirements and source solutions for linking and implementing new products specific to studies/projects.

Minimum Qualifications

• Bachelor's degree preferred, preferably in data management, biomedical informatics, computing science, information science or mathematical field.
• Experience in pharmaceutical industry or in clinical or academic research organizations is required.
• Demonstrated experience in implementing data entry tools while maintaining data completeness and data accuracy is required.
• Demonstrated experience with research data lifecycles - from submissions to data collection, quality assurance, data processing, analysis, knowledge translation and data storage/retention is required.
• Experience using REDCap and other electronic data capture (EDC) systems for clinical research is required.
• Significant experience in the facilitation of data collection and data collector training, including development and implementation of Data Management Plans, SOP's and training documents is required.
• Demonstrated understanding of the importance of conducting sound and ethically responsible research is required.
• Demonstrated proficiency in prioritizing workloads, multitasking, and fulfilling targets on time both independently and in a team setting is required.
• Creative with an ability to problem solve and investigate new ideas
• Strong knowledge of Health Canada, FDA, EMA and other regulatory requirements as well as ICH/GCP as it relates to data management is required.
• Excellent oral and written communication, interpersonal, organizational, problem solving and time management skills; meticulous attention to detail; ability to work independently as well as in a team environment.
• Strong commitment to client service with a positive and professional approach

Preferred Qualifications

• Demonstrated evidence of continuing education (e.g., area-specific certificates and courses) is an asset.
• Demonstrated experience in collecting and coding clinical data and in data security and privacy in health research settings is an asset.
• Experience in medical terminology and data coding systems including ICD-CM 9/10, ATC, etc is an asset.
• Experience with a wide range of software packages including MSOffice, SQL, SharePoint, REDCap (required) SAS, and R is an asset.
• Implemented French translations into data collection applications and training documents is an asset.

At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.The University of Alberta is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Mxc3xa9tis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and the University to apply.Note: This opportunity will be available until midnight November 27, 2024, Edmonton, Alberta local time.

University of Alberta