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Clinical Study Start-Up Project Manager - Norway

Laboratory Corporation of America Holdings (Covance)

Oslo, Norway

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: 'Helvetica',sans-serif;">Labcorp is looking for a Study Start-Up Project Manager to be office based near Oslo, Norway.  </span><span style="font-family: 'Helvetica',sans-serif;">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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: 'Helvetica',sans-serif;">This particular job will be 100% client dedicated with a global Pharmaceutical company</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: 'Helvetica',sans-serif;">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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: 'Helvetica',sans-serif;">This position has a significant impact on how Norway can deliver country-specific trial commitments and objectives, especially during start-up. </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-size: 10.0pt;">Core competencies</span></strong><span style="font-size: 10.0pt;">:</span></p><ul><li><span style="font-size: 10.0pt;">Expertise of core clinical systems, tools and metrics</span></li><li><span style="font-size: 10.0pt;">Excellent English skills</span></li><li><span style="font-size: 10.0pt;">Strong coordination and organizational skills</span></li><li><span style="font-size: 10.0pt;">skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.</span></li><li><span style="font-size: 10.0pt;">Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support.</span></li><li><span style="font-size: 10.0pt;">Ability to make decisions independently with limited oversight from manager.</span></li><li><span style="font-size: 10.0pt;">Requires strong understanding of local regulatory environment</span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 10.0pt;">Behavioural Competency Expectations:</span></strong></p><ul><li><span style="font-size: 10.0pt;">Problem solving is essential to this position.</span></li><li><span style="font-size: 10.0pt;">Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable.</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 10.0pt;">Specific examples of common problems include: </span></p><p style="margin-left: .25in;"><span style="font-size: 10.0pt;">1) Issues in budget / CTRA negotiations, </span></p><p style="margin-left: .25in;"><span style="font-size: 10.0pt;">2) Quality and compliance issues, </span></p><p style="margin-left: .25in;"><span style="font-size: 10.0pt;">3) Regulatory and legal issues, and</span></p><p style="margin: 0px; padding-left: 30px;"><span style="font-size: 10.0pt;">4) issues related to functional area deliverables that could jeopardize protocol milestones.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-family: 'Helvetica',sans-serif;">Other Information:</span></strong></p><p style="margin-bottom: .0001pt;"><span style="font-family: 'Helvetica',sans-serif;">This role is a full time & permanent position to be employed through Labcorp. For more information please contact Andy Smith on +44 (0) 7775 848 250 or mail andy.smith@covance.com </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-family: 'Helvetica',sans-serif;">Key words:</span></strong></p><p style="margin-bottom: .0001pt;"><span style="font-family: 'Helvetica',sans-serif;">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</span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10.0pt;">Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related </span><span style="font-size: 10.0pt;">experience</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10.0pt;">5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business</span></li></ul>

Job posted: 2021-11-17

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