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Senior Study Start Up Specialist - Denmark

Laboratory Corporation of America Holdings (Covance)

Denmark

<h2>Job Overview:</h2><p style="margin: 0px;">labcorp Drug Development is looking to recruit a Study Start-Up Specialist in Denmark within our Clinical Operations department.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">This role will involve dealing with the contract, budgets and submissions so a wider than average start-up position. We can potentially consider a Study Site Co-ordinator from a hospital environment or even a CRA looking for less travel. There are 3 in the Danish team currently so a close-knit working environment.</p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong>Key Responsibilities: </strong></p><p style="margin: 0px;"> </p><ul><li>Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance</li><li>Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines</li><li>Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.</li><li>With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.</li><li>May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.</li><li>Escalate study issues appropriately and in a timely fashion.</li><li>Update study documents when there are changes in study personnel/study amendments.</li><li>Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.</li><li>Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.</li><li>Undertake ta<span style="font-family: verdana, geneva;">sks delegated by senior team members, depending upon country and situational requirements with proper supervision.</span></li><li><span style="font-family: verdana, geneva;">Perform other duties as assigned by management.</span></li></ul><p style="margin: 0px;"><span style="font-family: verdana, geneva;"><strong>Other Information:</strong></span></p><p style="margin: 0px;"> </p><p style="margin-bottom: .0001pt;"><span style="font-family: verdana, geneva;">This role is a full time & permanent position to be employed by Labcorp. For more information please contact Andy Smith on +44 (0) 7775 848 250 or mail andy.smith@covance.com </span></p><h2>Education/Qualifications:</h2><ul><li>University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)</li></ul><h2>Experience:</h2><ul><li>experience with start up activities , or an equivalent combination of education and experience to successfully perform the key responsibilities of the job</li><li>Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process</li></ul>

Job posted: 2021-12-10

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