Job Description

The Data Management Assistant's overall purpose is the verification of study data while developing/maintaining the study database, and study reports as well as providing detailed information in response to inquiries from staff and study centres.
Evaluate clinical, laboratory and diagnostic case report forms and identify deviant, discrepant or inconsistent data reporting.
The ability to apply knowledge of the Study Protocol, Good Clinical Practice, Standard Operating Procedures, study plans and other study documents to daily activities. The ability to apply critical thinking skills to ensure accuracy, effectiveness and efficiency of the study and study related tasks.
Database Development

• Collaborate with the Research Coordinator, Research Assistant and or Principal Investigator to coordinate the design and implementation of the study data management database(s), including testing.
• Collaborate with the Research Coordinator, Research Assistant and or Principal Investigator to create, program, test, implement and maintain study specific Edit Checks.

Study Start Up

• Create/revise/test/approve Case Report Forms (CRFs), and Reference pages.
• Collaborate with study team to ensure that sites are provided with the appropriate start up materials.
• Collate with preparing site initiation power point presentations, creation of study protocol and CRF binders, Log shipment of start-up supplies.
• Communicate with sites to ensure all specific regulations are being met.

Edit checks and Reports

• Collaborate with study team and database programmers to implement and test study specific edit checks.
• Study specific report creation, implementation, analysis and distribution.

Data Validation

• Oversees the collection, entry, delivery, verification, management, analysis and reporting of data.
• Conduct, analyze and summarize data audits.
• Identify deviant, discrepant, or inconsistent data.
• Applies quality control notes to identify issues with data.
• Identify issues with database implementation.
• Identify protocol deviations and lost to follow-up patients.

Follow-up with sites

• Data quality, overdue visits, source document collected for adjudication.
• Site questions and concerns, site training.

Site correspondence

• Responds to inquiries from study centres regarding data quality/issues.
• Conduct conference calls with the Sponsor and Clinical Research Associates for site updates.

Prepare study materials

• Prepare for study meetings (collect materials, create presentation slides).
• Organize travel arrangements.
• Order supplies.
• Create slides for scientific meetings.

Qualifications
Research/Data Management Experience:
Ability to assess data analytically for quality and consistency.
High level of attention to detail, organizational and problem solving skills to ensure overall best data quality.
Ability to effectively integrate the requirements for database design and functionality to achieve a high level of data quality.
Ability to manage data including database design and development, CRF creating, edit checks, testing and validation while utilizing required systems.
Ability to assess and analyze large volumes of data while isolating trends and identifying discrepancies and errors to ensure clean data.
Computer skills
Knowledge of REDCap and databases such as ORCCID and IRIS.
Proficient in Microsoft Office (Word, Excel, , and PowerPoint).
Communication
Excellent written and oral communication skills and ability to work flexible hours
Ability to work with a multidisciplinary team (local, national, and international) to produce high quality study results.
Ability to delegate responsibility to other staff and work independently as required.
Assets:
Bachelor's degree in science preferred
Working knowledge of HHSC systems, processes, organizational structure and SOPs.
Clinical Trial experience.
GCP, TCPS2 training.

Skills Required