Clinical Operations Manager - Finance

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 - Finance
Remote Montreal
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.
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
• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements .
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
  

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 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
• 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 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.
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