- You’ll work alongside a knowledgeable, creative and energetic group of colleagues focused on providing exceptional service and best-in-class solutions to our life sciences clients.
- You’ll develop close relationships with our clients as part of a team that understands how to meet, and exceed, each of our clients’ specific needs.
- You’ll be a part of each study’s success and your focus, consistent effort and good ideas will help us to continue to improve everything we do so that we keep “wowing” our clients.
Are you a good fit for us? Are we a fit for you?
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 firstname.lastname@example.org and we’ll be in touch.
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.
- Senior Quality Assurance Associate
- Clinical SAS Programmer
- Clinical Coding Specialist
- Software Tester
- Project Manager Associate
- Customer Care Associate
Senior Quality Assurance Associate
The Senior Quality Assurance Associate is involved with the direct and daily administration of the Quality Management System, working closely with the Director, Quality Assurance and members of the Project Management, Data Management, Software Engineering, Product Management, and Customer Care teams. This is a full-time opportunity reporting to the Director of Quality Assurance.
Core responsibilities include:
- Provide oversight of activities to ensure compliance with GxPs.
- Prepares key quality documentation (deviations, change control, and CAPA documentation) that impact quality of products.
- Review and approve GxP documentation including deployment records.
- Liaise with internal groups to ensure detailed investigations and root cause analysis for non-compliance issues in a timely manner.
- Aids in performing compliance audits in all departments and prepares results reports for Director, Quality Assurance. Ensures outstanding corrective actions from the audits to ensure timely corrective actions.
- Demonstrates a primary commitment to product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Participate in the compilation of KPIs.
- Oversee the compliance of the internal training process.
- Investigates non-conformance’s to ensure recurrence is prevented.
- Participates in special projects as required in other areas of Quality and Compliance as assigned by the Director, Quality Assurance
- Perform other related duties as assigned.
Job Requirements Include the following:
- Minimum 3+ years in a Quality Assurance role in either the pharmaceutical or clinical industry
- Minimum 3+ years working experience in a QA Investigative Role
- Prior work experience in Health Care Industry is essential..
- Working knowledge of clinical trial process
- Thorough knowledge of GxP
- A good understanding of ISO:9001
- Excellent oral, written communication, time management and organizational skills
- Ability to work independently in a team environment
- Proficient in Microsoft Word, excel, Power point, Project and Outlook
- Strong attention to detail
Clinical SAS Programmer
We are seeking a Clinical SAS Programmer to contribute to the preparation, validation and maintenance of SAS programs to generate SDTM and ADaM SAS datasets, specifications, tables, Listings, Figures and graphical displays of clinical trial and safety data.
The position is also responsible for developing SAS programming codes and generating complete and accurate statistical output reports of trial data in well-defined formats.
- The incumbents will be responsible for performing statistical programming, validation, and quality control of the SDTM and ADaM datasets and output tables/listings/graphs.
- Design and specification of study data tabulation models and analysis data models.
- Generate complete and efficient analysis data models following approved dataset designs or specifications.
- Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians.
- Writes, validates and maintains SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial and safety data.
- Contribute to the establishment of client specific programming standards/conventions/procedures for assigned clients when required.
- Bachelor’s Degree in a related field required (e.g. Statistics, Computer Science), Masters preferred.
- Proven SAS experience and expertise as demonstrated in previous work (SAS certification is an asset).
- Extensive knowledge of CDISC standards programming – SDTM and ADaM.
- An understanding of relevant safety and efficacy ICH guidelines as well as relevant clinical trials regulations.
- Experience with relational databases.
- Demonstrated leadership ability to effectively manage statistical programming activities and integrate them with the entire clinical trial operation.
- Good organizational and time management skills with the ability to manage concurrent projects and adjust to changing priorities.
- Detail-oriented, customer- and quality-focused.
- Excellent interpersonal skills; Demonstrated ability to work independently and as part of a team.
- Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions.
Clinical Coding Specialist
The Clinical Coding Specialist is responsible for the creation, ongoing management and closeout of coding activities of Fusion projects, by working closely with the Data Management; Project management Teams and other members of Company Departments.
The Clinical Coding Specialist role has the follow responsibilities:
- Coding Module Implementations
- Routine(daily/weekly) coding for assigned projects using Coding Conventions
- Coding Listing Specs creation and listing validation
- Support Client Communications with coding related topics
The Clinical Coding Specialist should have experience in the following areas:
- Knowledge of the regulatory requirements for MedDRA and WHODrug coding
- Knowledge of Medical Terminology
- Medical /healthcare background knowledge/education
- Clinical Research Knowledge/Education
- Knowledge of Coding SOP – DM5
- Experience preparing coding documentation such as Coding Conventions Document, Coding listings specification for coding data transfers
- Knowledge of Fusion and Coding Module Functionality
- Internal Coding Training and MedDRA/WHODrug Webinar participation
- Ability to address a Sponsor/Medical Monitor coding comments using solid knowledge of medical terminology and MedDRA/WHO regulatory requirements and the previous experience with similar therapeutic area projects
- Ability to implement and update a Coding Module and Dictionaries requested by the Sponsor for all required projects
- Ability to test Coding Builds during full deployment testing
Job Function Overview
You will work closely with the Software Engineers, Product Management Operations and Quality Assurance, with a focus on:
- Implement and maintain an automated test suite for the central functionality of our product. This test suite is flexible and adapts to the different requirements of our many Clients.
- Participate in manual testing of the product.
- Coding Listing Specs creation and listing validation
- Focus heavily on regression testing, integration testing, unit testing, stress testing, performance testing, and system testing.
- Create and maintain all relevant documentation, including test design, test scenarios, test plans, test cases, reports, etc.
- Lead training in proper testing and relevant documentation techniques.
- Work with the CEO, Product Management team, Project Management team, and Software Engineers in key product initiatives.
- Excellent written and oral communication skills
- Bachelor’s Degree or higher in Software Engineering, computer science, or another software related field.
- 3-5 years experience in software testing
- Excellent time management skills.
- Team player
- Experience with presentations a plus
- 5+ years’ experience in software testing
- Experience in Health Care
- Experience with the clinical trial process
- Understanding of industry specific regulatory compliance and frameworks
Project Manager Associate
ABOUT THE COMPANY
Axiom Real-Time Metrics Inc. is an established company in the life science sector continuing to experience strong growth after more than 15 years in the marketplace.
One of the contributing factors is our unique eClinical suite that gives our customers a single, intuitive and powerful software platform to manage their entire clinical study. Our Fusion platform delivers an easy-to-use, powerful and cost-effective eClinical / EDC / Data Management solution, designed specifically for small to medium biotech, pharma and CROs. From powerful, intuitive EDC to complete data management, study operations and monitoring, we ensure that our clients can focus on the clinical research, not the technology needed to conduct it.
Axiom believes that exceptional customer service is key to a great business relationship. We work extremely hard to deliver high quality study and data management solutions. Driving and supporting Axiom’s services is Axiom’s Customer Care team, who are available 24/7 and work with end-users to address questions, issues and refresh training.
JOB FUNCTION OVERVIEW
The Project Management Associate is a member of our Clinical Operations Department and provides daily management of clinical trials and registry projects for clients across the globe. The position combines project management, timeline management, financial management and Axiom application support responsibilities
- Managing and scheduling interdepartmental and client meetings to inform on project resolutions and updates;
- Communicating with key internal and external stakeholders about upcoming deadlines and assignments;
- Overseeing; validating; managing issues, tasks and project documents for the Axiom product configuration;
- Facilitating, implementing, verifying and operating electronic case report forms.
- Managing the development of client deliverables including study environments, project management and clinical reports;
- Overseeing the management of project timelines and milestones projects;
- Ensuring adherence and compliance to standard operations procedures for projects.
WHAT YOU BRING TO THE TABLE
- You are smart. You are driven. You like working with others who are smart and driven. You are ready to take your career to the next level in a fast moving and growing organization.
- Having an interest and curiosity for science and technology, you want to work with an organization that makes a difference in people’s lives, one that truly partners with its employees and its clients; clients who are at the forefront of research in their disciplines.
- Clinical Research or Project Management Certification or other related discipline is an asset;
- Entry-level through 2 years of experience;
- Ability to multitask and prioritize in a fast-paced environment;
- Ability to communicate in English at a business level, written and verbal;
- Excellent organizational, time management and interpersonal skills;
- Team player with strong attention to detail and excellent problem-solving skills;
- Tech savvy with advanced knowledge of Microsoft Office and the ability to quickly learn our proprietary Fusion eClinical software
APPLYING FOR THIS POSITION
- All interested applicants are requested to submit a resume and cover letter. We thank all applicants for their interest but only those selected for interview will be contacted. No phone calls or third-party recruiters please.
Customer Care Associate
Driving and supporting Axiom’s services is our Customer Care team, who are available 24/7 and work with end-users to address questions, issues and refresh training.
Responsibilities and Duties
Your core responsibilities as a Customer Care Associate would include the following:
- Provide professional assistance to global end-users with customer service and technical inquiries
- Maintain ownership of open incidents and provide End-Users with status updates until a resolution is reached
- Investigate and troubleshoot issues, escalating to the appropriate teams when necessary
- Track and report all inquiries / issues within Axiom’s ticket management system
- Issue training certificates to end-users upon training completion
- Document study-related contact information and activate electronic signatures
- Actively participate in internal training sessions and stay up-to-date on key study information
- Assist the Project Management Team during initiation, maintenance and close-out of projects, which may include training, client communications, implementation of new / updated functionality and validation
- Build professional working relationships by providing prompt, enthusiastic and accurate customer service
- Distribute customer satisfaction surveys and collect end-users feedback
- Work across multiple time zones and communicate with remote team members
- Maintain a working knowledge of Axiom’s products and services.
- You are the first point of contact with our End-Users and as such, will provide outstanding customer support that mirrors the quality of Axiom’s products and services.
Qualifications and Skills
You are smart. You are driven. You like working with others who are smart and driven. You are ready to take your career to the next level in a fast moving and growing organization.
Having an interest and curiosity for science and technology, you want to work with an organization that makes a difference in people’s lives, one that truly partners with its employees and its clients; clients who are at the forefront of research in their disciplines.
What you bring to the table:
- Minimum 2 years in a Customer Service environment.
- Experience in the technology, pharma or healthcare industries an asset.
- Strong attention to detail.
- Excellent oral, written communication, time management and organizational skills.
- Ability to work independently in a team environment.
- Proficient in Microsoft Word, excel, Power point, Project and Outlook.
All interested applicants are requested to submit a resume and cover letter. We thank all applicants for their interest but only those selected for interview will be contacted. Applicants must have current work authorization in Canada.
No phone calls or third-party recruiters please.
Company paid medical, dental, vision, Healthcare Spending Account.
Job Type: Full-time
- Customer Service: 2 years