Systems Coordinator, Clinical Compliance and Operations
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The company markets 11 medicines through its orphan, rheumatology and primary care business units. Horizon seeks candidates who are passionate, experienced and driven to exceed expectations. Horizon offers ambitious compensation, extensive benefits including health, dental and vision, vacation and more.
Responsibilities:
- Coordinates, facilitates and/or conducts the review and selection process for new or replacement Clinical systems, including but not limited to, electronic (e) data capture (EDC), e-signature, e Trial Master File (TMF), Clinical Trial Management System (CTMS), secure data and document transfer mechanisms
- Manages implementation and maintenance of new and replacement Clinical systems
- Manages access to Clinical systems
- Manages upgrades to Clinical systems
- Manages vendors relevant to Clinical systems
- Manages Clinical SharePoint sites, including access
- Interfaces with IT and other Horizon functions and departments as needed to ensure effective systems support for the Clinical functions
- Develops and implements appropriate processes relevant to Clinical systems
- May manage Clinical email-boxes as assigned
- May also be responsible for managing, directing, or mentoring Clinical staff, and consultants or contractors
- Other tasks as assigned
- Ensures that systems, SharePoint sites, data/document transfer mechanisms and Clinical shared Email-boxes are compliant with applicable laws, regulations, directives, and regulatory guidance
As a member of the Clinical Compliance function, the Systems Coordinator is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.
Qualifications and Skills Required:
- BA or BS (or equivalent ex US) degree
- Thorough knowledge of 21 CFR Part 11 as well as US and global privacy regulations
- 3
years' experience in the medical product industry - Strong analytical skills.
- Proficient in Microsoft Office, Adobe Acrobat, SharePoint , and clinical systems
- Professional, proactive demeanor
- Strong interpersonal skills
- Excellent written and verbal communication skills
Essential Core Competencies:
- Action Oriented
- Problem Solving
- Organization
- Functional/Technical Skills
- Priority Setting
- Drive for Results
- Strategic Agility
- Intellectual Horsepower
- Dealing with Ambiguity
Horizon Pharma 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.
Estimated Salary: $20 to $28 per hour based on qualifications.
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