Covance 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.
- 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.
- Ability to make decisions independently with limited oversight from 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.
This role is a full time & permanent position to be employed through Covance. For more information please contact Andy Smith on +44 (0) 7775 848 250 or mail firstname.lastname@example.org
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 ManagerEducation/Qualifications:
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
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