About Calyx

Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.

We seek to change the world, and with the support of our teams across the globe, we flourish together. At Calyx, we are one team. We learn, grow and win together.

Are you ready to help change the world?

Apart from job satisfaction, we can offer you:

HEALTH:
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)

YOURSELF :
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings

WEALTH:
401(k) program, life & accident insurance and disability insurance

About the role

Job Purpose:

Entry Level Administrative Work

Under supervision of a mentor. Perform administrative tasks associated with all phases of medical imaging projects. Act as liaison with investigator site personnel to provide initial site contact, ongoing support, and provide study supplies for projects when needed. Support process teams through query management, site management, shipping and receiving study materials. Ensure the site personnel have a good understanding of the requirements of the study working with investigator sites on site surveys and site qualification

Entry Level Processing:

Under supervision of a mentor. Perform analysis by quality checking and processing medical imaging data and images for clinical trials in compliance with study protocols and applicable regulatory agencies.

Key Accountabilities:

Portfolio, Program & Project Support

• Assists with the compilation of portfolio, program and project management reports.
• Maintains program and project files from supplied actual and forecast data

Database Administration

• Assists in database support activities.
• Carries out agreed database maintenance and administration tasks.

Image management

• Collection of Medical Imaging data
• Perform quality checking and processing medical imaging data of assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21 CFR Part 11), applicable departmental and company-wide SOPs, and project specific protocol compliance
• Perform Image Processing techniques applicable across therapeutic areas
• Ensure compliance with study protocols
• Issue and resolve queries with investigator sites and academic centers to ensure follow-up on imaging-related issues.
• Validate and maintain a database of medical imaging data and associated results

Knowledge Management

• Maintains a knowledge management database, by leveraging knowledge of a specialism in order to capture and classify content, taking expert advice when required

Customer Service Support

• Responds to common requests for service by providing information to enable fulfilment.
• Promptly allocates unresolved calls as appropriate.
• Maintains records, informs users about the process and advises relevant persons of actions taken.

Other

• Carryout any other reasonable duties as requested.

Skills:

• Excellent interpersonal, verbal and written communication skills
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Must have the ability to work methodically in a fast-paced, time-sensitive environment
• Demonstratable ability to apply critical thinking to problems and tasks
• Proactively participates in skills improvement training and encourages their teams to participate
• A self-starter and able to work under own initiative
• Competent in Microsoft Office Suite (including Word, Excel, PowerPoint)

Knowledge and Experience:

• Experience using tools to communicate progress to Stakeholders
• Experience of regulated environments
• Experience of working in and knowledge of the life sciences sector
• Solid Professional experience in the same or very similar role

Education:

• Bachelor's Degree in a technical discipline (Math, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience
• English: Fluent

Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.