Clinical Data Specialist, Home/Office-Based - IQVIA Biotech

POSITION TITLE:      Clinical Data Specialist

REPORTS TO:              Associate Manager/Manager, Data Management

BASIC FUNCTIONS:

Clinical Data Specialist position is to ensure a complete and clean database per industry standards and client specifications.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Clinical Data and Query Review
  • Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (AE/CM compares, Inclusion/Exclusion review, etc.), Aggregate Checks (DM listings), and Reconciliation (LAB, SAE, ECG, and other vendors).
  • Assist with other data reviews for Biostatistics,  Medical Review, Sponsor,  and other ad hoc reports
• System Development and  Validation Creation
  • Provide input for and may create or draft CRF design, edit check specification and DM listings.
  • Consolidate comments from internal/sponsor for discussion and approval.
  • Oversee the entry of data in the Development or QC systems that will be used for validation.
  • Perform validation of data management system (CRF content & edit checks) and associated DM reports or listings, and associated change control.
  • Provide feedback to other DMs and Programmers to improve the deliverables.
• Maintain or Create Documentation for studies:
  • Create and update DM documentation as directed by the DM lead including: Data Management Plan (along with supporting DM documents), CRF Completion guidelines, Data Entry guidelines, Trial Design Document, edit specifications, reconciliation guidelines, and report specifications.
• Study Management:
  • Back-up or Primary DM for internal/client team meetings
  • Produce and Review Metric reports for internal/external project team
  • Provide feedback to improve the system or reports
  • Discuss roadblocks for getting processes done in a timely manner
  • Review project budgets and staffing projections for data management activities
  • Provide the DM lead or PM with status updates on tasks that are assigned

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to work well with technical and clinical team members
• Ability to interact with entire clinical team (CRAs, Safety, Biostatisticians, etc.) and answer questions related to specific data collection concerns
• Knowledge of clinical trials data processing concepts
• Ability to create DM study documents (CRF guidelines, trial design document, edit checks, etc.)
• Ability to perform research for data collection and protocol specific topics
• Knowledge of unique data collection concepts (RECIST, CDASH, Local Labs, Adjudication, etc.)
• Good knowledge of data management processing systems (preferred systems are InForm, Rave, and Oracle Clinical)
• Organized and thorough with attention to details
• Effective Interpersonal skills and good communications skills, verbal, written and listening
• Willingness to learn new things and teach others
• Ability to accept constructive criticism
• Administrative Organization (such as being able to organize/save emails appropriately, etc.)
• Ability to adhere to detailed instructions
• Effective logical thinking ability in regards to Problem-solving skills
• Proficiency in computer applications: Windows, Excel, Word, Outlook etc.
• Ability to work independently

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)
• Travel, as required for office visits, bid defenses, Investigator Meetings, or other meetings as requested, not expected to exceed 40hrs per year.

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
• 3 years of clinical data management experience in pharmaceutical industry and/or contract research organization

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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.