Senior Clinical Research Associate

<p>Job Description</p><p></p><p><span><span>If you want to:</span></span><span> </span></p><ul><li><p><span><span>Join a multi-award-winning leading biopharmaceutical company</span></span><span> </span></p></li><li><p><span><span>Be part of growing team of Clinical Research Associates </span></span><span> </span></p></li><li><p><span><span>Use new technology and smart monitoring tools </span></span><span> </span></p></li><li><p><span><span>Have flexibility of work and good work-life balance</span></span><span> </span></p></li></ul><p><b><span><span>Apply today! </span></span><span> </span></b></p><p><span><span> </span></span><span> </span></p><p><span><span>On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites. </span></span><span> </span></p><p><span><span> </span></span><span> </span></p><p><b><span><span>Your key <span>responsibilities: </span></span></span><span> </span></b></p><ul><li><p><span><span>Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit &amp; non-visit contact reports.</span></span><span> </span></p></li><li><p><span><span>Ensure by monitoring activities that:</span></span><span><span> </span></span><span> </span></p><ul><li><p><span><span>Data generated at site are complete, accurate and unbiased.</span></span><span> </span></p></li><li><p><span><span>Subjects' right, safety and well-being are protected.</span></span><span> </span></p></li></ul></li><li><p><span><span>Perform clinical study site <span>management/monitoring</span> activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.</span></span><span> </span></p></li><li><p><span><span>Coordinate and manage various tasks in collaboration with other sponsor roles.</span></span><span> </span></p></li><li><p><span><span>Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</span></span><span> </span></p></li><li><p><span><span>Identify and assess site performance, quality or compliance problems</span></span><span><span><span> </span></span></span><span><span>in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.</span></span><span> </span></p></li><li><p><span><span>Manage and maintain clinical trial systems such as CTMS, eTMF, etc. </span></span><span> </span></p></li><li><p><span><span>Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.</span></span><span> </span></p></li><li><p><span><span>Follow the country strategy defined by Country Director.</span></span><span> </span></p></li></ul><p><span><span> </span></span><span> </span></p><p><b><span><span>You should apply if you have:</span></span><span> </span></b></p><ul><li><p><span><span>Min. 3 years</span></span><span><span><span> </span>of direct site management (monitoring) experience in a bio/pharma/CRO.</span></span><span> </span></p></li><li><p><span><span>Proven skills in site management, including management of site performance and patient recruitment.</span></span><span> </span></p></li><li><p><span><span>Good IT skills, ability to learn and operate new IT applications. </span></span><span> </span></p></li><li><p><span><span>Ability to understand and analyse data/metrics. </span></span><span> </span></p></li><li><p><span><span>Capable of managing complex issues, works in a solution-oriented manner.</span></span><span> </span></p></li><li><p><span><span>Fluent in English (verbal and written) and local language, excellent communication and presentation skills.</span></span><span> </span></p></li><li><p><span><span>Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.</span></span><span> </span></p></li><li><p><span><span>M.A/ M.Sc degree with strong emphasis in medical/bioscience background.</span></span><span> </span></p></li><li><p><span><span>Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.</span></span><span> </span></p></li><li><p><span><span>Valid driving license.</span></span><span> </span></p></li></ul><p></p><p>Current Employees apply <a href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p><p>Current Contingent Workers apply <a href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld" rel="noopener noreferrer" target="_blank">HERE</a></p><p></p>