Clinical Operations Intern
Toronto, CA
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.
This is what you will do
The GRD R&D Clinical Operations intern will be responsible for supporting the GRD R&D Clinical Operations team with Trial Master File (TMF) management and other activities related to clinical study management.
You’ll be responsible for:
- Support the Lead Clinical Trial Administrator in preparation of study TMF Plan and Map, and any other Clinical Study Plans as required;
- Support with study documents upload to the eTMF, conduct quality checks and quality reviews throughout the duration of the study as outlined in the TMF Plan;
- Maintain assigned trackers and information as required for study conduct (e.g., Sponsor oversight tracker, regulatory tracker, etc.);
- Support with vendor management;
- Support with drafting, finalizing and distributing study team meeting minutes;
- Assist in managing the study mailbox and filing any relevant communications in the eTMF;
- Assist in checking the costs invoiced to Chiesi based on planned study activities vs actual.
You will need to have
- Pursuing a BS or MS in clinical research or related fields;
- Fluent in English, both written and spoken;
- Proficiency in MS Office;
- Knowledge of ICH GCP E6, clinical research regulatory requirements and legal work frame.
Location
Hybrid - Must be available to work at least one day per week out of the Woodbridge office.
What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.
We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.
Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
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