Senior Manager, Data Management

<b>Company Overview </b><br>Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognise the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to learn, adapt, and our tenacity to overcome barriers, together.<br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Calibri, sans-serif;"><b>Opportunity Overview</b></span></span></span></span><br><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">The Senior Manager, Data Management acts as the Lead Data Manager for multiple clinical studies and/or a clinical development program.&#160; The successful candidate will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout.&#160; They will be responsible for the oversight and management of clinical data management activities outsourced to CROs.&#160; The Senior Manager, Data Management will also contribute to the Rhythm data management operational improvement efforts to identify, develop, and implement departmental standards, applications, processes, and training.&#160;</span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Calibri, sans-serif;"><b>Responsibilities and Duties</b></span></span></span></span><ul style="margin-bottom:11px;"><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to scope of work and service agreements</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Responsible for CRO adherence to project timelines, from study startup through study closeout, ensuring high quality and integrity of all deliverables &#160;</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Review data via listings and visualization tools to report on performance and quality; review will be performed with clinical data within studies and across multiple studies for trend analysis</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Contribute to the development, review and implementation of Clinical Data Management processes, policies and SOPs</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Participate in vendor qualifications and audits</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Oversee the planning, execution, and maintenance of major projects and initiatives, if required.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Lead data management study inspection readiness activities and the support of submission activities as needed.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Train and mentor DM staff or members of the clinical trial team on processes, projects, systems, and programs.</span></span></span></li><li style="margin-bottom:11px;margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Perform hands-on data management responsibilities, if required.</span></span></span></li></ul><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Calibri, sans-serif;"><b>Qualifications and Skills</b></span></span></span></span><ul style="margin-bottom:11px;"><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Bachelor&#8217;s degree in a science-related discipline, or equivalent work experience</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">6+ years working in clinical data management at a Sponsor organization with experience across multiple indications and EDC platforms </span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Experience developing initiatives designed to promote efficiency and productivity for data management operations</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Experience leading a team of CRO data managers to ensure the timely provision of DM deliverables</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Advanced hands-on knowledge of data management processes and EDC systems</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Experience with data visualization, analytics and reporting tools such as elluminate or SpotFire</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Strong project management skills, and ability to effectively lead and collaborate with various business functions</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Self-motivated, reliable team member</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">CDASH experience</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Demonstrated ability to influence without authority</span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Demonstrate initiative, sound judgment and flexibility</span></span></span></li><li style="margin-bottom:11px;margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:107%;"><span style="font-family:Calibri, sans-serif;">Solid understanding of clinical drug development processes</span></span></span></li></ul><br>This role will be home-office based. Candidates applying must be located in a centralized UK location and have easy access to transportation and airports.<br><br><b><i>More about Rhythm</i></b><i> </i><br><i>We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.&#160; Our team is passionate about&#160;expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. </i><br><br><i>At Rhythm our core values are:</i><ul><li><i>We are committed to advancing scientific understanding to improve patients&#8217; lives</i></li><li><i>We are inspired to tackle tough challenges and have the courage to ask bold questions</i></li><li><i>We are eager to learn and adapt</i></li><li><i>We believe collaboration and ownership are foundational for our success</i></li><li><i>We value the unique contribution each individual brings to furthering our mission</i></li></ul><br>&#160;