Study Start-Up Project Manager

4 weeks ago

Maidenhead, United Kingdom 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 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. This will include organization of initial applications and amendments to Competent Authorities and Ethics both within the UK via Combined Review and the Republic of Ireland via EUCTR application processes. Production of essential documentation such as country level ICFs for approval will be required along with other tasks such as organization of drug delivery, support of relevant safety reporting, recording and maintenance of the eTMF accordingly to strict deadlines as applicable.

This position has a significant impact on how the UK can deliver country-specific trial commitments and objectives, especially during start-up.

Qualifications, Skills and Experience

Core competencies :

Previous submissions experience is a MUST Excellent English skills Strong coordination and organizational skills Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM Ability to make decisions independently with limited oversight from SCOM Requires strong understanding of local regulatory environment Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Behavioral Competency Expectations:

Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 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. Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

Other Information:

This role is a full time position to be employed through Fortrea.

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