Start-Up Associate Manager/Com-R

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.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
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.
In this role, the selected candidate will serve as client’s contact for start-up and maintenance processes and oversight; be responsible for establishing a strong working relationship with client’s project teams; monitor and control start up project schedule and scope; proactively engage in both quality assurance and risk management activities to ensure project deliverables are met; and initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects.
Responsibilities Include

• Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
• 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.
• Responsible for clinical and ancillary supplies management.
• Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.
• Collaborate with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Oversee country and site budgets.

Education

• University degree (life science preferred)
• Thorough understanding of the drug development process
• Fluent in French and English, both written and verbal
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries (IRB/IEC etc.)

Experience

• Ability to lead and develop junior staff.
• Positive attitude and approach
• Works well independently as well as in team environment.
• Detail and process oriented
• Excellent communication skills, oral and written.
• Interact with internal and external customers with high degree of professionalism and discretion.
• 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.
• Good organizational and time management skills
• Flexible and adaptable to a developing work environment
• Self-motivation with the ability to work under pressure to meet deadlines.
• Multi-tasking capability.

Labcorp Is Proud To Be An Equal Opportunity Employer
As an EOE/AA employer, Labcorp 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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