Sr Manager, Clinical Data Management
Company: Horizon Therapeutics
Location: Deerfield
Posted on: May 23, 2023
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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
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