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Data Management Coordinator

1 month ago

Edmonton, Canada University of Alberta Full time

**Department** Faculty of Medicine & Dentistry - Medicine Dept

**Salary range** $73,849.29 to $102,918.30

**Hours per week** 40

**Grade** 11

**Posted date** November 14, 2024

**Closing date** November 27, 2024

**Position Type** Full Time - Trust Funded

**Description**:
**_This position is a part of the Non-Academic Staff Association (NASA)._**

This position offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits.

**Location - **This role is hybrid with a mix of remote and in-person.

**Working at the University of Alberta**
- The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, 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. **Learn more**.**

**Working for the Canadian VIGOUR Centre**

The 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.

**Position**

The 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.

**Duties**

Project 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.

Administrative
- Promotes compliance by monitoring the progress and performance of assigned operational p