Data Associate Jobs

Axiom Real-Time Metrics, Inc. the pre-eminent eClinical technology and managed services company in Canada delivering clinical trials on a global footprint, is seeking a Data Management Associate, Level II to join its team!

JOB FUNCTION OVERVIEW

This is a full-time Data Management Associate, Level II opportunity.

The Data Management Associate II is a member of the Clinical Operations Department and performs data management activities for one or more clinical trials and registry projects for clients globally. The Data Management Associate II works closely with the Lead Data Manager and has ongoing collaborations with members of the project team to ensure each project runs efficiently.

KEY RESPONSIBILITIES

• Responsibility for all aspects of data management for each study, including review of subject records, and issuing and resolution of queries where applicable
• Assist, where applicable, with the maintenance of the Axiom Fusion eClinical Suite application and study database in conjunction with the Lead Data Manager and Project Manager
• Assist with updating data management documents (including Data Management Plans, Data Integrity Plans, and Data Export Specifications) as per Client request
• Provide ongoing support for the management of the project and associated ancillary initiatives, (including assisting with interim analyses, database closeout/locks, reconciliations and coding) by working with internal project teams and external clients to coordinate all final database lock processes
• Responsibilities throughout lifecycle of a project
• Evaluate and add queries to data where applicable based on edit check outputs
• Remote site training, support, and communications from a data management perspective
• Assist where applicable in the development and implementation of site training and ongoing data management-related support
• Follow up on eCRF data entry and query completion with sites
• Responsible for validating data exports and data sets prior to release to the client
• Responsibilities related to project initiation
• Responsible for ensuring data integrity, performance of edit checks, and recommends applicable changes/updates to the Data Integrity Plan as per Sponsor request/Protocol amendments and/or eCRF updates
• Effective management of all data and reports (management reports and/or clinical data reports) based on study protocol and overall data objectives
• Close, ongoing collaboration with members of project team to ensure project runs smoothly and efficiently and that overall strategic objectives are realized
• Data management and data quality assurance
• Responsibilities related to project maintenance
• Assist with all Data Management activities including the validation and implementation of eCRF reports in the Axiom Fusion Reporting Tool required throughout the study in a timely fashion

MINIMUM REQUIRED EDUCATION & EXPERIENCE

• Demonstrated flexibility and adaptability
• Excellent organization, prioritization, time management and interpersonal skills
• Well-developed written and verbal communication skills
• Perceptive listening skills
• Enthusiastic, smart, resourceful, analytical
• Strong attention to detail
• Basic understanding of web-based technologies and browsers
• BSc / Life Sciences / Health Sciences
• Experience performing Data Management in EDC systems
• At least 2 years experience in health-careworking at CRO / Hospital / pharmaceutical industry – Data Management
• Ability to work independently within a team environment
• At least 2 years experience in Data Management
• Demonstrates a good understanding of Clinical Data Management processes– study startup, maintenance, database lock
• Adept at multi-tasking and problem-solving
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook

IDEAL REQUIREMENTS

• 2+ years in a professional service clinical data management environment
• Familiarity with GCDMP, CDISC standards (CDASH) and data structures
• Knowledge and experience ofmedical coding dictionaries (WHODrug / MEDDRA)
• Certificate in clinical research or related field
• Working knowledge of Good Clinical Practices, FDA and Health Canada regulations
• Fluency in other language(s) in addition to English
• 2+ Experience in health-care working at a CRO / Hospital / pharmaceutical industry
• Proven to take initiative

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted.No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.