Senior Business Analyst- Operations/Clinical Trials (Montreal QC)

at  Montrium Inc

Are you looking to work as Senior Business Analyst - Operations/Clinical Trials for a company providing best in class software products to the Life Sciences industry?
Montrium is building its next generation platform for managing clinical documentation, in a cloud-native, microservices architecture based on the Microsoft Azure platform ecosystem, and is looking for a Senior Business Analyst, to add to our talented team of software professionals.

JOB DESCRIPTION:

Reporting to the Director of Product, the Senior Business Analyst will be involved in all aspects of software definition of the Connect product.

As a member of the Product group, you will:

• Collaborate with the product manager and SMEs to define requirements and specifications needed for the product creation and the evolution of the software.
• Collaborate in the implementation strategy.
• Collaborate with the designers, product owners and other developers during the refinement and implementation phases to develop a best-in-class Montrium SaaS platform.
• Maintain the requirements and specification up to date throughout the product life cycle.
• Perform analysis of regulatory changes and identify new requirements and opportunities for innovation in collaboration with the Director of Compliance and other regulatory SMEs.
• Conduct reviews, critiques, and workshops.
• Reach out to potential or current customers to gather insights for requirement validation.
• Participate in benchmarking activities related to the Life Sciences and other industries.
• Join a culture that is data and technology-focused, agile and high-performing.
• Have a drive to learn, enjoy taking initiative, and grow into leadership within the organization.
• Interface with multi-functional teams.
• Interact with programmers during system development.
• Keep up to date with technical and industry developments.
• Have full flexibility to work remotely and from our amazing Old Montreal office.
• Manage your own schedule and work-life balance in exchange for sustained, and sustainable, results.
• And other tasks as required.

EXPERIENCE:

• 5 or more years of experience working within clinical operations/clinical trials/regulatory operations and systems development.
• Relevant bachelor’s degree or higher.
• Good knowledge of GCP and other regulations relating to clinical trials (GAMP 5, FDA 21 CFR part 11, ISO 13485, ICH).
• Good understanding of clinical trial conduct, and software development processes.
• Knowledge of TMF (Trial Master File) & Reference model an asset.
• Sporadic international travel might be required.
• Ability to incorporate new information quickly and work autonomously.

SOFT SKILLS:

• Written and spoken fluency in English and French is essential (other languages are an asset).
• A sense of curiosity and unafraid to ask lots of questions.
• Good analytical skills.
• Excellent time management and interpersonal skills, team-player, ability to integrate well with others and capacity to lead by influence and broker consensus.
• Comfortable challenging the status quo and questioning existing practices.
• Good interpersonal and communication skills, excellent team-player.
• Thrive in a collaborative cross-functional environment.

NEXT STEPS:

It’s important to Montrium that we continue to build on our talented team that is as diverse as our customers and where all employees feel a deep sense of belonging, where they can thrive and grow.
We encourage great and talented individuals who bring a range of perspectives to apply for our open positions.
If this career opportunity interests you, or if you have any questions?
If you are innovative, digital, and passionate?
Montrium is looking for someone like you to join our growing team and make things connect!
Contact us!

Please refer the Job description for details