Clinical Study Start-Up Project Manager - Norway
Oslo, Norway
5 dager siden

Job Overview :

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.

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.
  • 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.

    Other Information : Key words :

    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

    Education / Qualifications :

  • Bachelor's Degree in Business Finance / Administration / Life Science or equivalent Health Care related experience
  • Experience :

  • 5 years of experience in clinical research or combined experience in Clinical Research and Finance / Business
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