Senior Study Manager, Oncology

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><span style="font-family: verdana, geneva; font-size: 10pt;"><strong><span style="color: black;">Senior Study Manager - Oncology</span></strong><strong><span style="color: black;"><br />Remote in the USA or Canada</span></strong><span style="color: black;">  </span></span></p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;"><span style="font-family: verdana, geneva; font-size: 10pt;"><span style="color: black;">***<strong>Position leads Phase 1-3 Clinical Trials and oversees medical monitoring.  This is not a laboratory/research scientist role.</strong><br /> <br />Why settle for one thing when you can have everything? <br /> <br />Covance by labcorp gives you the best two-for-one opportunity for career growth.   Who doesn’t want twice the perks?  Working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!</span></span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; color: black; font-family: verdana, geneva;"><br />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, Covance has an FSP opportunity to match your area of expertise.</span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; color: black; font-family: verdana, geneva;"><br />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 style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; color: black; font-family: verdana, geneva;">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 style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 10pt; font-family: verdana, geneva;"><br />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.<br /> <br />In this role, the selected candidate will lead or support studies and be the operational point of contact for trial execution and deliverables. You will manage all Operation Activities including managing the Clinical Trial Team (CTT) and supporting clinical supplies planning. Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets. Additional responsibilities include:</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 10pt; font-family: verdana, geneva;"> </span></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Manages deployment and interactions with external vendors (e.g., IVRS, PRO) </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Initiates planning for Investigator meeting and protocol training. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Plans and assesses protocol ancillary supplies </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Completes trial set-up and maintains SPECTRUM </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Initiates recruitment/retention planning & enrollment tracking </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for tracking study related details (e.g., specimens, queries) </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Oversees protocol training activities including IMs and CRAs training meetings </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ensures appropriate postings to investigative site portals </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Point of escalation for study related operational issues </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for operational details at Operational Reviews </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for creating and maintaining project schedule and collaborating with Program Lead</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Sets up and maintains Trial Master File (eTMF) </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Ensures alignment of budget with protocol needs </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for executing protocol within the budget </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for risk assessment, mitigation planning and execution </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for creating and maintaining ADI logs </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Develops study related manuals (e.g., administrative binder, lab manuals) </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Manages Emergency Unblinding (EUB) Call Center activities </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Co-authors newsletters with CS </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Approves contracts, invoice payments and change orders for vendors, as necessary </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for end of study reconciliation (clinical & ancillary supplies) </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Oversees all HQ close-out tasks </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Supports CS activities as needed to achieve CTT deliverables </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Interface with External Data Coordination and Data Management </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Responsible for quality control and inspection readiness at all times</span></li></ul><p style="margin-bottom: .0001pt;"> </p><h2>Education/Qualifications:</h2><ul><li style="margin-left: 0in;"><span style="font-family: verdana, geneva; font-size: 10pt;">BS/BA/MS/PhD with 7+ yrs clinical research experience</span></li></ul><h2>Experience:</h2><ul><li><span style="font-family: verdana, geneva; font-size: 10pt;">Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead Study Manager required</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">Proven ability to meet aggressive timelines</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">MS Project experience preferred</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">Excellent Excel and Power Point skills required</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">Excellent oral (including presentation) and written communication, computer/database management, and project management skills required</span></li><li><span style="font-family: verdana, geneva; font-size: 10pt;">Must have experience managing oncology studies</span></li></ul>