Sr Manager, Clinical Data Management

Company: Horizon Therapeutics
Location: Deerfield
Posted on: May 23, 2023

Job Description:

Working at Horizon is more than a job - it''s personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We''re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we''re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Position Summary: The primary role of this position is to support planned and ongoing clinical trials including overall management/oversight of all data management activities to ensure that studies are executed within the agreed timelines and according to the agreed standards and processes. Responsibilities: Manages all assigned clinical study work, inclusive of studies supported internally or studies outsourced to a contract research organization (CRO) Ensures that clinical study milestones related to data management are met for assigned clinical studies Acts as the main point of contact for client and vendor communication on assigned clinical studiesOversees vendor activities for the clinical database creation and maintenance activities for assigned clinical studiesPerforms database development user acceptance testing activities in support of assigned clinical studiesPrepares or provides review of the data management plan and CRF completion guidelines for assigned clinical studiesContributes to the preparation of protocols and other clinical study documents led by cross-functional team membersEnsures completeness, accuracy and consistency of clinical data and data structure for assigned clinical studiesSupports data management activities such as clinical data review, third party data reconciliation including ECGs, central lab, biomarker, IVRS, PK, SAE reconciliation and local lab data review Follows standard clinical data management practices as outlined in SOPsEnters data queries into the EDC system to be resolved at investigational sites and manages the resolution of those queriesOther activities as assigned Travels as needed to execute assigned responsibilities and tasks Required Qualifications, Skills and Education: 4+ years in clinical data management pharma/CRO industry experienceUniversity/college degree (life science, pharmacy or related subject preferred) CCDM preferred Proficient in Microsoft Office Professional, proactive demeanor Good written and verbal communication skills Good interpersonal and project management skills Able to collaborate effectively with internal and external study management teams to meet project timelines SCDM Certified Clinical Data Manager (CCDM) preferredFamiliar with CDASH/CDISC standards.Knowledge of MedDRA and WHODrug codingGood knowledge of EDC systems, Medidata Rave preferredIn-depth knowledge of clinical data management processesBroad knowledge of drug development processHas a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverablesHorizon Core Values & Competencies: Growth Manages Ambiguity Strategic Mindset Demonstrates Self-awareness Cultivates Innovation Develops Talent Accountability Drives Results Ensures Accountability Decision Quality Transparency Courage Collaboration Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). ''Fully vaccinated'' is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Arlington Heights , Sr Manager, Clinical Data Management, Healthcare , Deerfield, Illinois