Start-up Associate Manager/com-r
5 months ago
Start-up Associate Manager/COM-R
Hybrid - Montreal, QC
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.
We are seeking a Clinical Operations Manager - Regulatory to lead start-up team during study start-up phase liaising directly with Lead Start Up Project Manager or Project Lead, core team members and the client, as applicable.
Responsibilities include:
- Execution and oversight of clinical trial country submissions and approvals for assigned protocols.- Development of local language materials including local language Informed Consents and translations.- Collaborate with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.- Oversee country and site budgets.- Partner with local clinical team/s to successfully deliver clinical and financial contracts within fair market value.- Manage and track clinical research-related payments - Payment reconciliation at study close-out.- Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.- Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.- Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials.
**Requirements**:
- University degree required (life science preferred)- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries (IRB/IEC etc.)- Thorough understanding of the drug development process- Fluent in French and English, both written and verbal- Good organizational and time management skills- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred- Excellent communication skills, oral and written- Self-motivation with the ability to work under pressure to meet deadlines- Works well independently as well as in team environment- Detail and process oriented- Interact with internal and external customers with high degree of professionalism and discretion- Multi-tasking capability- Ability to lead and develop junior staff- Flexible and adaptable to a developing work environment
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our
Privacy Statement
.
-
Start-up Associate Manager/com-r
5 months ago
Montréal, Canada Fortrea - Organic Full timeStart-up Associate Manager/COM-R Hybrid - Montreal, QC As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across...
-
Regulatory and Start Up Specialist
5 months ago
Montréal, Canada Precision for Medicine Full time**Position** **Summary**: The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed...
-
Study Start Up Associate Ii
5 months ago
Montréal, Canada ICON plc Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
Study Start Up Associate I
5 months ago
Montréal, Canada ICON plc Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
-
R&d Lab Associate
5 months ago
Montréal, Canada nomic Full time**About us**: Nomic was founded with the purpose of making biology easier to measure. To do this, we have untangled some of the most difficult problems in protein profiling. Our team is combining DNA nanotechnology, high-dimensional flow cytometry, laboratory automation, and machine learning to develop the world’s highest throughput proteomic platform: the...
-
Clinical Research Start-up Trial Manager
5 months ago
Montréal, Canada Translational Research in Oncology Full timeTranslational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a **Start-Up Manager **to join our **Strategy and Clinical...
-
Special Services Associate
7 months ago
Montréal, Canada The Home Depot Canada Full timeService Desk associates are responsible for following through on all Customer Order Management (COM) orders from beginning to end and until the customer is satisfied including but not limited to special order, install and website orders. They ensure that customers receive both the products they ordered and the services they requested in a timely and accurate...
-
Service Desk Associate
5 months ago
Montréal, Canada The Home Depot Canada Full time(Special Services Associate 4-month - part-time contract ) Service Desk associates are responsible for following through on all Customer Order Management (COM) orders from beginning to end and until the customer is satisfied including but not limited to special order, install and website orders. **Position Responsibilities** - Ensure customers receive...
-
Service Desk Associate
5 months ago
Montréal, Canada The Home Depot Canada Full timeSpecial services associate - part-time contractual 4 months Service Desk associates are responsible for following through on all Customer Order Management (COM) orders from beginning to end and until the customer is satisfied including but not limited to special order, install and website orders. **Position Responsibilities** - Ensure customers receive...
-
Clinical Operations Manager
5 months ago
Montréal, Canada ICON Full timeICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: This role is accountable for performance and compliance for assigned...
-
R&d Project Lead
3 months ago
Montréal, QC, Canada The People Co. Full timeOur client, a manufacturing company located near Montreal, QC is looking for a R&D Project Lead to join their team. What you will do in this role: - Independently lead product development projects from formulation through scale up and start up. - Conduct lab tests, pilot plant and large-scale tests within manufacturing facilities to optimize formulation...
-
Horticultural R&d Manager
5 months ago
Montréal, Canada Vizva AgroTech Canada Ltd. Full time**Company Description**: Vizva AgroTech is a Montreal-based company that designs and builds fully automated and cost-efficient hydroponics greenhouses. Our focus is on addressing the reduction of arable land and increase in global food demand. **Role Description**: This is a Full-time on-site role for a Horticultural R&D Manager. The Horticultural Manager...
-
Market Research Associate
3 months ago
Montréal, QC, Canada MD Analytics Full timeMD Analytics, a rapidly growing Market Research company, is seeking a talented Research Associate to actively support and manage market research projects in the Healthcare and Pharmaceutical space. **The Opportunity: Research Associate based in the Greater Montreal Area **_(work from home)_** Working with a team in Montreal, you will be responsible for...
-
Administrative Project Coordinator
5 months ago
Montréal, Canada The Group Master Full time**Master, for over 70 years** We lead in HVAC-R and have been recognized among Canada's best-managed companies since 2010. As the foremost private HVAC-R distributor in the nation, we have over 1,300 active employees across 55+ branches, 4 distribution centers, spanning from British Columbia to the Atlantic provinces, and nearly 30 branches in the United...
-
R&D Metallurgical Engineer
3 weeks ago
montréal, Canada Fordia Full timeIt all starts with people. People like you. At Epiroc, our employees benefit from a passionate team that supports them sustainably, efficiently and safely. No challenge is too great for our curiosity and perseverance to improve productivity, safety and sustainability. Our engineering team enjoys combining efficiency, collaboration and fun at...
-
R&D Metallurgical Engineer
3 weeks ago
montréal, Canada Fordia Full timeIt all starts with people. People like you. At Epiroc, our employees benefit from a passionate team that supports them sustainably, efficiently and safely. No challenge is too great for our curiosity and perseverance to improve productivity, safety and sustainability. Our engineering team enjoys combining efficiency, collaboration and fun at work. Descrip...
-
R&D Metallurgical Engineer
2 months ago
montréal, Canada Fordia Full timeIt all starts with people. People like you. At Epiroc, our employees benefit from a passionate team that supports them sustainably, efficiently and safely. No challenge is too great for our curiosity and perseverance to improve productivity, safety and sustainability. Our engineering team enjoys combining efficiency, collaboration and fun at work. We offer...
-
R&D Metallurgical Engineer
2 months ago
montréal, Canada Fordia Full timeIt all starts with people. People like you. At Epiroc, our employees benefit from a passionate team that supports them sustainably, efficiently and safely. No challenge is too great for our curiosity and perseverance to improve productivity, safety and sustainability. Our engineering team enjoys combining efficiency, collaboration and fun at work. We offer...
-
R&D Metallurgical Engineer
3 weeks ago
montréal, Canada Fordia Full timeIt all starts with people. People like you. At Epiroc, our employees benefit from a passionate team that supports them sustainably, efficiently and safely. No challenge is too great for our curiosity and perseverance to improve productivity, safety and sustainability. Our engineering team enjoys combining efficiency, collaboration and fun at...
-
R&d Associate
5 months ago
Montréal, Canada Eli Health Full time**About us** Eli is the women's health company making continuous hormone monitoring possible. We empower people to understand their body every day and improve their health outcomes across their lives. Hormones are at the core of our health, yet they remain a black box. Eli is on a mission to unlock this box by developing a product that provides real-time...