This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Study Start-Up Project Manager. Copenhagen, Denmark.

Laboratory Corporation of America Holdings (Covance)

Copenhagen, Denmark

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt;">We are looking for a Study Start-Up Project Manager to be office based in Copenhagen, Denmark.</p><p style="margin: 0in 0in 0pt;"> </p><p style="margin: 0in 0in 0pt;">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.</p><p style="margin: 0in 0in 0pt;"> </p><p style="margin: 0in 0in 0pt;">This particular job will be 100% client dedicated with a global Pharmaceutical company</p><p style="margin: 0in 0in 0pt;"> </p><p style="margin: 0in 0in 10pt;"><span style="color: black;">The main responsibilities will be regulatory tasks (submission to EC, HA and writing ICF) and also budget/finance tasks (contracts and  budget).</span></p><p style="margin: 0in 0in 10pt;"><span style="color: black;">This position has a significant impact on how Denmark can deliver country-specific trial commitments and objectives, especially during start-up. </span></p><p style="margin: 0in 0in 10pt;"> </p><p style="margin: 0in 0in 10pt;"><strong><u><span style="font-size: 11pt;">Qualifications, Skills and Experience</span></u></strong></p><p style="margin: 0in 0in 10pt;"><strong><span style="font-size: 11pt;">Core competencies</span></strong><span style="font-size: 11pt;">: </span></p><ul><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Expertise of core clinical systems, tools and metrics </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Excellent English skills </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Strong coordination and organizational skills </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="color: #000000; font-size: 11pt;">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 style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Ability to make decisions independently with limited oversight from SCOM </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Requires strong understanding of local regulatory environment </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. </span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 11pt;">Behavioural Competency Expectations: </span></strong></p><ul><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Problem solving is essential to this position. </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;">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. </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English. </span></li><li style="margin: 1em 0px 1em 35.4pt;"><span style="font-size: 11pt;"> 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.</span></li></ul><p style="margin: 0px;"><strong>Other Information:</strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;">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</p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Life Science degree</p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 11pt;">5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business</span></p>

Job posted: 2021-07-12

3