Clinical Data Coordinator (Home-Based) - IQVIA Biotech

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

POSITION TITLE:      Data Coordinator

REPORTS TO:              Associate Manager/Manager, Data Management or Designee

BASIC FUNCTIONS:

Data Coordinator position is to assist and support the data manager to ensure a clean database per IQVIA Biotech standards and client specifications.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Data and Query Review:
  • Perform data entry
  • Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (Lab, SAE, ECG, etc.), and limited other assistance for review from others (Biostatistical, Medical review, Client, etc.)
• Locking eCRFs:
  • Review data for completeness according to the Data Management Plan
  • Lock eCRFs by Item, Form, Visit and/or Subject
• Validation Assistance:
  • Enter data in the Development or QC systems that will be used for validation.
  • Assist with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control.
  • Provide feedback to the Lead DM and Programmers to improve the deliverable.
• Documentation Support:
  • Perform Scanning/Indexing
  • Update DM study documentation including: Data Management Plan (along with supporting DM documents), CRF Completion guidelines, Data Entry guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, and/or Report specifications
• Communication and Reporting:
  • Provide feedback to improve the data management system or reports
  • Discuss roadblocks for getting processes done in a timely manner
  • Produce Study Metric reports to internal/external project team
  • Provide the DM lead or PM with status updates on tasks that are assigned

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to work with technical and clinical team members
• Ability to interact with CRAs and other key members of the team
• Knowledge of clinical trials data processing concepts
• Comprehension of clinical study documents (CRF guidelines, protocol, etc.) and SOPs and Working Practices
• Efficiency and organizational skills to meet deadlines
• Effective Interpersonal skills
• Good communications skills, verbal, written and listening
• Willingness to learn new things
• Ability to accept constructive criticism
• Organized and thorough with attention to details
• Administrative Organization (such as being able to organize/save emails appropriately, etc.)
• Ability to adhere to detailed instructions
• Logical thinking ability regarding Problem-solving skills
• Ability to Multi-task
• Proficiency in computer applications: Windows, Excel, Word, Outlook etc.
• Work independently with limited oversight

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

• 1-year experience in a clinical/scientific environment

CLASSIFICATION (US):

This position is classified as non-exempt under the Fair Labor Standards Act; employees are eligible for overtime compensation subject to prior approval.

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Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.