Senior Clinical Research Associate II - Home Office, Denmark

<p>A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 70,000 employees advance life-changing medicines across a wide range of therapeutic areas.</p><p>In this role, you will work with our renowned key sponsors and advance the development of innovative, life-changing medications for a variety of therapies.</p><p></p><p>If you are looking to broaden your therapeutic expertise whilst gaining exposure, taking on responsibility and developing your career within a world-class pharmaceutical working environment, this is an excellent opportunity!</p><p></p><p></p><p><b>What we have to offer:</b></p><ul><li><p>work as part of a diverse and stable team</p></li><li><p>in-depth onboarding, including personal support from your mentor</p></li><li><p>flexible working hours and compensatory time off in lieu</p></li><li><p>a permanent employment contract</p></li><li><p>travel time = work time</p></li><li><p>highly competitive compensation packages including local allowances and additional insurances</p></li><li><p>regular, merit-based salary adjustments</p></li><li><p>significant employer contributions to an attractive pension scheme</p></li><li><p>excellent training and career development opportunities</p></li><li><p>strong support from Line Management, your team and more than 20'000 colleagues worldwide</p></li><li><p>the world's most renowned pharmaceutical companies and innovative biotech pioneers as our satisfied, repeat customers for many years</p></li></ul><p></p><p></p><p><b>Your responsibilities:</b></p><ul><li><p>Own all aspects of site management as described in the project plans</p></li><li><p>Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study</p></li><li><p>Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements</p></li><li><p>Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries</p></li><li><p>Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports</p></li><li><p>Review progress of projects and initiate appropriate actions to achieve target objectives</p></li><li><p>Interact with internal work groups to evaluate needs, resources and timelines</p></li><li><p>Act as contact for clinical trial suppliers and other vendors as assigned</p></li><li><p>Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs</p></li><li><p>Independently perform CRF reviews</p></li><li><p>Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems</p></li></ul><p></p><p></p><p><b>Your profile:</b></p><ul><li><p>Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, (veterinary) medicine, nursing, etc.; in lieu of the former, a completed vocational education or professional experience (e.g. as study nurse, study coordinator...)</p></li><li><p>Professional experience in a related function with a focus on independent site monitoring in Denmark</p></li><li><p>Familiarity with applicable Danish and international regulatory requirements such as ICH / GCP</p></li><li><p>Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and preferably in relevant software solutions for clinical trials, e.g. eTMF (e.g. Veeva Vault)</p></li><li><p>Effective time management and organizational skills and a keen attention to detail</p></li><li><p>Valid driver's license</p></li><li><p><b>Excellent communication skills in business fluent Danish and English – both spoken and written – are a must</b></p></li></ul><p></p><p></p><p>REMOTE</p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>