Senior Clinical Research Associate

<p>Job Description</p><p></p><p><span>If you want to:</span></p><ul><li><span>Join a multi-award-winning leading biopharmaceutical company</span></li><li><span>Be part of growing team of Clinical Research Associates </span></li><li><span>Use new technology and smart monitoring tools </span></li><li><span>Have flexibility of work and good work-life balance</span></li></ul><p>Apply today!</p><p></p><p>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.</p><p></p><p>Your key responsibilities:</p><ul><li>Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit &amp; non-visit contact reports.</li><li>Ensure by monitoring activities that:<ul><li>Data generated at site are complete, accurate and unbiased.</li><li>Subjects' right, safety and well-being are protected.</li></ul></li><li>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.</li><li>Coordinate and manage various tasks in collaboration with other sponsor roles.</li><li>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.</li><li>Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.</li><li>Manage and maintain clinical trial systems such as CTMS, eTMF, etc.</li><li>Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.</li><li>Follow the country strategy defined by Country Director.</li></ul><p></p><p></p><p>You should apply if you have:</p><ul><li>Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.</li><li>Proven skills in site management, including management of site performance and patient recruitment.</li><li>Good IT skills, ability to learn and operate new IT applications.</li><li>Ability to understand and analyse data/metrics.</li><li>Capable of managing complex issues, works in a solution-oriented manner.</li><li>Fluent in English (verbal and written) and local language, excellent communication and presentation skills.</li><li>Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.</li><li>M.A/ M.Sc degree with strong emphasis in medical/bioscience background.</li><li>Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.</li><li>Valid driving license.</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><p><b>Search Firm Representatives Please Read Carefully </b><br/>Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. </p><p></p><p><b>Employee Status: </b></p>Regular<p></p><p><b>Relocation:</b></p><p></p><p><b>VISA Sponsorship:</b></p><p></p><p><b><span>Travel Requirements:</span></b></p><p></p><p><b>Flexible Work Arrangements:</b></p>Remote<p></p><p><b>Shift:</b></p><p></p><p><b>Valid Driving License:</b></p><p></p><p><b>Hazardous Material(s):</b></p><p></p><p><b>Job Posting End Date:</b></p>10/29/2024<p><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>