Associate Director, Clinical Data Management

Location
Lake Forest, IL, United States
Posted
Oct 30, 2020
Ref
R0002128
Discipline
Clinical, Clinical Data
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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:
Responsible for the independent timely management and oversight of all assigned data management clinical programs, studies and activities. Clearly communicates issues and proposes viable solutions. Works effectively cross-functionally on study planning, conduct and close-out activities. Enforces standardization and provides expertise to project teams to promote data collection consistency. Works cooperatively with vendors to mitigate risks so that clinical study timelines are met. Assists with the development of the data management department strategies. Mentors other data management team members on processes and technologies used in support of clinical studies. May have people management responsibilities.

Responsibilities:
  • Independently 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 programs or studies
  • Oversees all assigned clinical program work on behalf of data management
  • Proactive management of clinical study documentation for assigned programs or studies to ensure data management audit readiness
  • Serves as a point of contact for other functional areas in need of data management expertise
  • Leads all activities involved in the clinical database creation and maintenance processes utilizing Electronic Data Capture (EDC) systems and integrated tools
  • Leads or serve as a key team member on technology-related projects that directly or indirectly impact data management processes
  • Identifies ineffective clinical data management practices, propose modifications and implement new solutions
  • Participates in study level budget review activities for clinical programs and maintain responsibility for tracking and updates throughout the duration of the clinical program
  • Assists in the development of key performance indicators (KPIs) for data management
  • Uses metrics and KPIs to establish key deliverable expectations within the data management group and to monitor vendor performance
  • Develops a strong partnership with cross-functional colleagues at Horizon to facilitate problem solving at the program and study levels
  • Participates in vendor selection for data management, technologies, and other services related to data collection and storage
  • Reports to and supports the Director, Data Management in departmental activities (e.g. recruiting and organizational efficiency)
  • Other activities as assigned
  • Travels 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 communication and interpersonal skills
  • Excellent organizational skills and ability to prioritize tasks
  • Experience with people management and development of staff
  • Self-directed, technically adept, and a recognized leader maintaining a strategic prospective with regard to data management processes
  • 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
  • Excellent knowledge of EDC systems, Medidata Rave preferred
  • In-depth knowledge of clinical 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

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.