Clinical Operations Manager

Clinical Operations Manager - Regulatory page is loaded Clinical Operations Manager - Regulatory Apply locations Montreal - Quebec time type Full time posted on Posted 2 Days Ago job requisition id 239928

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.

Clinical Operations Manager - Regulatory

Montreal (Hybrid)

Must be able to speak, read and write in French

We are seeking an exceptional person with study startup experience that is focused on advancing their career in Clinical Research to the next level. In this role, you will be responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols; Develop 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 and partner with local clinical team/s to successfully deliver clinical and financial contracts within fair market value. 

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. 

Additional responsibilities include:

• 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:

Education

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.

Experience

• 5 or more years of experience in clinical research
• Experience negotiating and developing local language materials including local language Informed Consents and translations.
• Experience interacting with IRB/IEC and Regulatory Authority for assigned protocols.
• 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 along with good organizational and time management skills.
• Self-motivation with the ability to work under pressure to meet deadlines.
• Works well independently as well as in a team environment.
• Detail and process oriented
• Positive attitude and approach
• 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
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com .

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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 . 

Similar Jobs (1) Clinical Operations Manager - Finance locations Montreal - Quebec time type Full time posted on Posted 30+ Days Ago

Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide.

As a member of Fortrea’s Global Talent Network, you'll:

• Be the first to know about exciting opportunities that align with your career interests.
• Stay informed about the latest trends and developments in the clinical research industry.
• Be invited to exclusive events and meet with Fortrea leaders to learn more about our company and culture.

#J-18808-Ljbffr

---