Senior Manager, Clinical Data Management

Ultragenyx Pharmaceutical · United States - Remote

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Data Leadership (Heads of data, directors, managers.)

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cgor

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<div class="content-intro"><div><strong>Why Join Us?</strong></div> <div> </div> <div><em>Be a hero for our rare disease patients</em></div> <div><em> </em></div> <div>At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. </div> <div> </div> <div>Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.</div> <div> </div> <div>If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3> <p style="text-align: left;"><strong><em>ultra</em></strong><em>focused – Work together to fearlessly uncover new possibilities</em></p> <p><span data-contrast="auto">The Senior Manager of Data Management is accountable for the overall Data Management success for his/her Disease Monitoring Program (DMP) clinical studies. The ideal candidate is a dynamic, driven and decisive data management professional who is a self-starter, thrives in a fast-paced environment and is looking for the rare and exciting opportunity to have a significant foundational impact on a growing data management department.</span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p> <p><span data-contrast="auto">This position is responsible for ensuring achievement of his/her own goals as well as other departments and project goals and objectives. The position may have line management responsibilities and will continue to perform hands-on activities.</span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.</p> <h3 style="text-align: left;"><strong>Responsibilities:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Facilitate and perform cross-functional sponsor EDC user acceptance testing.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Facilitate the development and implementation of key data and metrics reports/listings.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> </ol> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">Bachelor’s degree or higher in the scientific, biological, statistical, or computer science field or related discipline.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Minimum 5-8 years of clinical trial data management experience in the pharma/biotech industry.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong experience in CRO, FSP and vendor management with consistent track record of on-time quality deliverables.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Extensive technical experience using electronic data capture systems.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">In-depth knowledge of DM industry standards, best practices, and CDISC/CDASH implementation.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Ability to adapt and manage competing and rapidly changing priorities.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Effective in proactively identifying issues and driving team towards creative solutions and smart decisions.</span><span data-ccp-props="{"201341983":2,"335559738":120,"335559739":120,"335559740":336}"> </span></li> </ol> <p><span style="color: rgb(255, 255, 255);"><em>#LI-CS1 </em><em><span class="ui-provider dir dis c d e f g h i j k l m n o p q r s t dit diu w x y z ab ac ae af ag ah ai aj ak">#LI-Remote</span></em></span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><em>The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.</em></p> <p><em><br>This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.</em></p></div><div class="title">Pay Range</div><div class="pay-range"><span>$178,700</span><span class="divider">—</span><span>$220,700 USD</span></div></div></div><div class="content-conclusion"><div> </div> <div><strong><em>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</em></strong></div> <div> </div> <div><strong><em>·         Generous vacation time and public holidays observed by the company</em></strong></div> <div><strong><em>·         Volunteer days</em></strong></div> <div><strong><em>·         Long term incentive and Employee stock purchase plans or equivalent offerings</em></strong></div> <div><strong><em>·         Employee wellbeing benefits</em></strong></div> <div><strong><em>·         Fitness reimbursement</em></strong></div> <div><strong><em>·         Tuition sponsoring</em></strong></div> <div><strong><em>·         Professional development plans</em></strong></div> <div> </div> <div><em>* Benefits vary by region and country</em></div> <div> <p><strong>Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at </strong><a href="mailto:talentacquisition@ultragenyx.com"><strong>talentacquisition@ultragenyx.com</strong></a><strong>.</strong></p> </div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/"><em>CCPA Employee and Applicant Privacy Notice</em></a><em>.</em></div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a><em>.</em></div> <div> <p><strong>It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.</strong></p> </div> <div><strong>Note to External Recruiters</strong>: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed to<em>: </em><a class="postings-link" href="http://mailto:talentacquisition@ultragenyx.com/">talentacquisition@ultragenyx.com</a><em>.</em></div></div>