Lead Data Manager ABOUT THE COMPANY A bit about Axiom: – Celebrating 22 years of operations ABOUT THE ROLE KEY RESPONSIBILITIES Project Initiation REQUIRED EDUCATION & EXPERIENCE • 5+ years in a professional service environment APPLY FOR THIS POSITION Data Management Associate, Level II ABOUT THE ROLE & COMPANY JOB FUNCTION OVERVIEW KEY RESPONSIBILITIES • Responsibilities related to project initiation o Assist with all Data Management activities including the validation and implementation of eCRF • Responsibilities related to project maintenance o Responsibility for all aspects of data management for each study, including review of subject • Responsibilities throughout lifecycle of a project o Data management and data quality assurance MINIMUM REQUIRED EDUCATION & EXPERIENCE IDEAL REQUIREMENTS APPLY FOR THIS POSITION
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We want to meet you if you’re smart, hard working, ambitious, and passionate about working in an entrepreneurial environment. Axiom is a great place for you if you’re eager to use all of your skills, interested in growing your responsibilities, and love to have fun while you do great work.
If you’re interested in working with us, but don’t see a role currently listed, please feel free to send us your resume, along with a short summary of your skills and why you’d like to work with us to careers@axiom.cc and we’ll be in touch.
Current opportunities
are posted below.To apply please submit your resume, along with a short summary of your skills and why you’re the best fit for this role, below. We look forward to hearing from you.
Axiom Real-Time Metrics
Toronto, Ontario
Full Time
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 Lead Data Managers to join its team!
– Have delivered hundreds of studies in over 25 countries
– Continuous growth of: Axiom Fusion eClinical Suite platform
– Constant investment in engineering and delivering new features
– Consecutively growing our team for the past 11 years
• New Clients
• Team expansion:
– Newly opened California Offices
As a Lead Data Manager, you will lead data management activities for one or more clinical trials or registry projects, working closely with the Project Manager, and the other members of each team.
• Assist Project Manager in the process of translating protocol, CRF and reports into documentation
necessary for implementation into Axiom data capture software
• Assist Project Manager in the process of translating protocol, CRF and reports into documentation
necessary for implementation into Axiom data capture software
• Collaborate with project team to define and develop data management and data integrity plan
• Assist with development and comprehensive testing of eCRF and reports within Axiom software
• Assist Project Manager, where appropriate, in the development of plans for site / client training and
ongoing support
Project Maintenance
Collaborate with project team to effectively and efficiently manage project through its lifecycle:
• Responsibility for all aspects of data management for each study, including the issue and resolution
of queries where applicable.
• Follow up on eCRF and query completion with sites.
• Evaluate and add queries to data where applicable based on edit check outcomes.
• Collaborate with Help Desk to ensure data related site questions are addressed promptly and
effectively.
• Ensure data collection and cleaning process is functioning smoothly and efficiently.
• Review data listings
Study Close-Out
Collaborate with project team to effectively and efficiently manage database close-out:
• Final review of outstanding data elements
• Communication with sites on outstanding queries
• Final query resolution
• Review of final data against the data management plan
• Execution of the database close-out check-list
• Data listings
eCRF / Axiom Application Support
• eCRF configuration / Implementation
• eCRF Validation
• eCRF related tools, including: Source Document Development / Study Completion Guidelines
• 3+ Experience in health-care / pharmaceutical industry
• Working knowledge of clinical / medical / biology
• Proven to take initiative.
• Working knowledge of clinical / medical / biology
• Proficiency in Microsoft Word, Excel, PowerPoint, Project and Outlook
• Enthusiastic, smart, resourceful, analytical
• Well-developed written and communication skills
• Perceptive listening skills
• Strong attention to detail
• Time management skills
• Ability to work independently within a team environment
• Adept at multi-tasking
• Basic understanding of web-based technologies and browsers
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.
Toronto, Ontario
Full Time
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!
A bit about Axiom:
– Celebrating 22 years of operations
– Have delivered hundreds of studies in over 25 countries
– Continuous growth of: Axiom Fusion eClinical Suite platform
– Constant investment in engineering and delivering new features
– Consecutively growing our team for the past 11 years
• New Clients
• Team expansion:
– Newly opened California Offices
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.
reports in the Axiom Fusion Reporting Tool required throughout the study in a timely fashion
o Effective management of all data and reports (management reports and/or clinical data reports)
based on study protocol and overall data objectives
o Assist with updating data management documents (including Data Management Plans, Data
Integrity Plans, and Data Export Specifications) as per Client request
o Assist where applicable in the development and implementation of site training and ongoing
data management related support
records, and issuing and resolution of queries where applicable
o 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
o Follow up on eCRF data entry and query completion with sites
o Evaluate and add queries to data where applicable based on edit check outputs
o Remote site training, support, and communications from a data management perspective
o Responsible for validating data exports and data sets prior to release to the client
o 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
o 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
o Close, ongoing collaboration with members of project team to ensure project runs smoothly and
efficiently and that overall strategic objectives are realized
• BSc / Life Sciences / Health Sciences
• At least 2 years experience working at CRO / Hospital / pharmaceutical industry – Data Management
• Demonstrates a good understanding of Clinical Data Management processes– study startup,
maintenance, database lock
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
• Enthusiastic, smart, resourceful, analytical
• Well-developed written and verbal communication skills
• Perceptive listening skills
• Strong attention to detail
• Excellent organization, prioritization, time management and interpersonal skills
• Ability to work independently within a team environment
• Demonstrated flexibility and adaptability
• Adept at multi-tasking and problem-solving
• Experience performing Data Management in EDC systems
• Basic understanding of web-based technologies and browsers
• Certificate in clinical research or related field
• 2+ years in a clinical data management environment
• 2+ Experience working at a CRO / Hospital / pharmaceutical industry
• Working knowledge of Good Clinical Practices, FDA and Health Canada regulations
• Familiarity with GCDMP, CDISC standards (CDASH) and data structures
• Knowledge of medical coding dictionaries (WHODrug / MEDDRA)
• Proven to take initiative
• Fluency in other language(s) in addition to English
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.Better decisions. Shorter timelines.
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