Clinical Operations Manager-regulatory, Fsp

3 weeks ago

Montréal, Canada Fortrea Full time

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.

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.

Additional 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**:
Education- University degree (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

Experience- 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.- 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

LI-Remote

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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