Project Manager
2 weeks ago
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. We are looking for a Study Start-Up Project Manager to be 100% home based anywhere in the UK .
This role would suit a Study Start-up specialist looking for a more senior & progressive role. This particular job will be 100% client dedicated with a global Pharmaceutical company.
The main responsibility will be management of multiple study 'Country level' Clinical Trial Applications and Maintenance tasks throughout their life cycle. Excellent English skills
Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
Requires strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. 1) Issues in budget/CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
This role is a full time position to be employed through Fortrea. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. 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. For more information about how we collect and store your personal data, please see our Privacy Statement . #
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