Clinical Trial Manager, Clinical Operations

5 months ago

Toronto, Canada Moderna Full time

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its presence in Toronto, Canada's largest city and a hub for biotech innovation. Our Toronto office focuses on commercial operations, ensuring the delivery of our innovative products to the Canadian market. We're inviting international talents to join our mission of transforming medicine and impacting lives worldwide.

The Clinical Trial Manager is a pivotal position within Moderna's Clinical Operations, offering the opportunity to oversee and ensure the success of clinical trials. This role demands a high level of precision, efficiency, and a proactive approach to managing complex trials, ensuring they meet all deliverables in terms of quality, compliance, and timing. Key to the role is robust vendor management, requiring effective collaboration with internal team members, sites, external vendors, and CROs. Reporting to the Director of Clinical Operations, and accountable to the Clinical Operations Lead for assigned studies, this role may span one or several trials, supporting a range of clinical operations activities.

**Here’s What You’ll Do**:Your key responsibilities will be**:
Day-to-day management of assigned clinical trial(s), ensuring all phases of the trial meet deliverables.

Effective communication with internal team members to maintain awareness of deliverables and adherence to timelines.

Managing the trial feasibility process and closely collaborating with the Clinical Operations Lead and/or assigned Clinical Trial Managers to execute clinical studies.

Drafting and distributing essential site materials such as training manuals and support documentation.

Monitoring clinical data for timely entry and readiness for data review meetings.

**Your responsibilities will also include**:
Periodic and thorough review of clinical data.

Review of clinical monitoring reports to ensure completion and identify issues promptly.

Ensuring trial samples are prepared and sent to vendors in alignment with trial deliverables.

Maintaining and reporting trial metrics.

Upholding Moderna and ICH/GCP standards across multiple regions in global trials.

Supporting the testing of clinical trial systems/databases (e.g., UAT).

Developing and maintaining strong, collaborative relationships within Moderna.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Act with dynamic range**: Driving strategy and execution simultaneously at every step, adapting to changing scenarios with agility.

**Pursue options in parallel**: Making informed decisions by exploring multiple pathways simultaneously, ensuring the best outcomes for our clinical trials.

**Here’s What You’ll Bring to the Table**:
At least 5 five years of trial coordination experience in a clinical research and industry environment

Relevant experience in global setting

Solid understanding of drug development

Good project management skills

Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies

Excellent verbal and written communication skills

Good organizational skills and attention to detail

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belo

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