Sr Manager, Data Management
Compensation: $91,730.00 - $131,820.00 /year *
Employment Type: Full-Time
Industry: Information Technology
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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.
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.
- Accountable for the data management (DM) deliverables across multiple studies and is responsible for all vendor(s) oversight for outsourced DM activities.
- Act as main point of contact for client and vendor communication for DM Activities
- Knowledgeable and experience with web-based Electronic Data Capture (EDC) systems, preferably Medidata RAVE, advanced understanding of the elements of database creation
- Creating/maintaining a library of standard CRFs
- Review and contribute to the preparation of protocols, CRF's and prepare or review/contribute to data management plans, data management reports and CRF completion guidelines
- Ensures completeness, accuracy and consistency of clinical data and data structure across all projects/studies.
- Support 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
- Knowledge of effective clinical data management practices
- Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
- Assist in database upgrades/migrations including performing User Acceptance Testing
- Participates in study level budget review activities for individual studies
- Uses metrics and key performance indicators (KPIs) to monitor vendor performance.
- Develops a strong partnership with FSP/CRO Lead Data Managers to ensure program level deliverables are on track.
- Participate in vendor selection for data management, interactive response technology (IxRS), and other services wherein data storage may be applicable
- Reports to and supports the Director, Biostatistics in departmental activities (e.g. recruiting and organizational efficiency)
- Travel as needed to execute assigned responsibilities and tasks
Required Qualifications, Skills and Education:
- 8+ years in clinical data management pharma/CRO industry experience
- University/college degree (life science, pharmacy or related subject preferred)
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Excellent written and verbal communication skills
- Experience with people management and development of staff
- Excellent 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) preferred
- Familiar with CDASH/CDISC standards.
- Knowledge of MedDRA and WHODrug coding
- In-depth knowledge of the drug development and data management processes
- Broad knowledge of drug development process
- Knowledge of time and cost estimate development and pricing strategies
- Has a good understanding of regulatory guidelines and issues (i.e., ICH GCP), and understands the connection to DM deliverables
- Ability to sit and stand for extended periods of time
- Ability to carry, handle and reach for objects
- Manual dexterity to operate office equipment, e.g. computer, phones, etc
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- 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.
Associated topics: data administrator, data integration, data manager, data quality, data scientist, database administrator, erp, mongo database, sql, sybase
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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