Fortrea is looking for a Study Start-Up Project Manager to be office based near Oslo, Norway.
This role would suit either an experienced CRA, perhaps looking for less travel, or an existing Study Start-up specialist looking for a more senior & progressive role.
This particular job will be 100% client dedicated with a global Pharmaceutical company
Under the oversight of the Sr. Clinical Operations Manager, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
This position has a significant impact on how Norway can deliver country-specific trial commitments and objectives, especially during start-up.
Qualifications, Skills and Experience
Core competencies:
- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- skilled knowledge of budget and contract negotiations, 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 or manager.
- Ability to make decisions independently with limited oversight from SCOM or manager.
- Requires strong understanding of local regulatory environment
Behavioural Competency Expectations:
- Problem solving is essential to this position.
- Requires the ability to pro-actively identify issues and risks, analyse 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.
Experience Requirements:
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
Educational Requirements:
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
Other Information:
This role is a full time & permanent position to be employed through Fortrea. For more information please contact Andy Smith at andy.smith@fortrea.com
Key words:
Clinical Research, SCRA, Clinical Research Associate, Norway Oslo GCP, Monitor, Monitoring, Senior Study Start-up Project Manager Clinical Research Associate, CRA I, Oncology, Office Based CRO, Pharmaceutical, Norway Oslo, Study Start up Project Manager
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.
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