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Sr Manager, Clinical Data Management

Location: Gaithersburg, MD
Company: Horizon Therapeutics
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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 studies
- Oversees vendor activities for the clinical database creation and maintenance activities for assigned clinical studies
- Performs database development user acceptance testing activities in support of assigned clinical studies
- Prepares or provides a review of the data management plan and CRF completion guidelines for assigned clinical studies
- Contributes to the preparation of protocols and other clinical study documents led by cross-functional team members
- Ensures completeness, accuracy, and consistency of clinical data and data structure for assigned clinical studies
- Supports 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 SOPs
- Enters data queries into the EDC system to be resolved at investigational sites and manages the resolution of those queries
- Other activities as assigned
- Travelsasneeded to executeassigned responsibilitiesand tasks
Qualifications *:
- 4+ years in clinical data management pharma/CRO industry experience
- University/college degree (life science, pharmacy, or related subject preferred)
- ProficientinMicrosoftOffice
- Professional,proactivedemeanor
- Goodwrittenand verbalcommunication skills
- Goodinterpersonaland projectmanagementskills
- Able to collaborateeffectively with internaland externalstudy managementteamstomeetprojecttimelines
- SCDM Certified Clinical Data Manager (CCDM) preferred
- Familiar with CDASH/CDISC standards.
- Knowledge of MedDRA and WHODrug coding
- Good knowledge of EDC systems, Medidata Rave preferred
- In-depth knowledge of clinical data management processes
- Broad knowledge of drug development process
- Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables
Physical Demands (additions as needed) *:
- Abilitytositand stand forextendedperiods of time
- Abilitytocarry,handleand reach forobjects
- Manualdexterityto operateofficeequipment,e.g.computer,phones,etc.
Horizon 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 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.
Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter , LinkedIn , Instagram and Facebook .
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