Clinical Research Manager / CRM

<h2>Job Overview:</h2><p style="margin: 0px;"><span>Labcorp Drug Development gives you the best opportunity for career growth. Working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.</span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span>Dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, we have an FSP opportunity to match your area of expertise.</span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span>You will enjoy the best of both worlds—all the benefits that come along with our Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.</span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span>Our FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.</span></p><p aria-hidden="true" style="margin: 0px;"> </p><p style="margin: 0px;"><span>Our reach is global – extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.</span></p><p aria-hidden="true" style="margin: 0px;"><span> </span></p><p style="margin: 0px;"><span>The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.</span></p><p aria-hidden="true" style="margin: 0px;"><span> </span></p><p style="margin: 0px;"><span>The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study.  As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships.</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><strong><span>Minimum Required:</span></strong></p><ul><li><span>Bachelor’s degree in science or comparable</span></li><li><span>Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries</span></li><li><span>Thorough understanding of the drug development process</span></li><li><span>Fluent in local office language and in English, both written and verba</span></li></ul><h2>Experience:</h2><p style="margin: 0px;"><strong><span>Minimum Required:</span></strong></p><ul><li><span>Minimum of 5-6 years in clinical research in which some experience should be in a CRA capacity.</span></li><li><span>1+ years of experience as a PM or CTL managing projects</span></li><li><span>Must have strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards.</span></li><li><span>Strong scientific and clinical research knowledge is required for this position.</span></li><li><span>A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.</span></li><li><span>The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.</span></li><li><span>The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance.</span></li><li><span>Good organizational and time management skills</span></li><li><span>Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred</span></li><li><span>Excellent communication skills, oral and written</span></li><li><span>Self-motivation with the ability to work under pressure to meet deadlines</span></li><li><span>Works well independently as well as in team environment</span></li><li><span>tail and process oriented</span></li><li><span>Positive attitude and approach</span></li><li><span>Interact with internal and external customers with high degree of professionalism and discretion</span></li><li><span>Multi-tasking capability.</span></li><li><span>Good computer skills with good working knowledge of a range of computer packages</span></li><li><span>Ability to lead and develop junior staff</span></li><li><span>Flexible and adaptable to a developing work environment</span></li></ul>