Sr. Clinical Data Analyst (Home-based) - IQVIA Biotech

IQVIA Biotech is seeking a Senior Clinical Data Analyst to join our growing team. Role can be home-based anywhere in the US or Canada.

BASIC FUNCTIONS:

Perform lead responsibilities on one or more projects, while maintaining a leadership role within the department.  Develop internal tools and add-ons to facilitate the processes and work flow for Project Programming, and other departments within Data Operations. Perform project-specific system setup and testing, data analytics, reporting and script development/execution in support of project programming and other project team efforts.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Maintain a leadership role within Project Programming
  • Under guidance from management, define and maintain departmental standards, SOPs and working practices; and lead process improvement initiatives.
  • Develop departmental training materials and execute training, for new and existing staff.
  • Make presentations to clients and other interested individuals about the processes and procedures of the Project Programming department.
• Perform as a SAS Data lead for projects
  • Review Data Management Plan and Data Review Plans for assigned project.
  • Review and provide feedback on project timelines and ensure that project tasks are completed timely and with acceptable quality.
  • Manage study sFTP site accounts.
  • Assume responsibility for project budget and perform monthly time projections.
  • Attend internal team meetings and relevant client team meetings, as needed.
  • Review and provide/collect SAS feedback on data transfer specifications and test transfers from external vendors as applicable for reconciliation purpose, SDTM and other programming tasks.
  • Review and provide/collect SAS feedback on eCRF development and changes and evaluate the impact on programming activities and exports.
  • File documentation associated with client delivery including project emails on an ongoing basis and perform final archival activity at study close.
• Manage and support project programming activities and deliverables
  • Develop specifications/test data for custom data files and data integration as requested by Sponsor; update blank CRFs with custom annotations.
  • Set up default clinical data transfer and/or perform scheduled and ad-hoc data transfers
  • Develop specifications/test data for SDTM, update blank CRFs with SDTM, and develop define.xml file for SDTM.
  • Define specifications/test data to facilitate vendor and/or SAE reconciliation, medical coding, investigator payments, data review (e.g., SAS data checks and patient profiles) and other needs, as requested.
  • Develop specifications to integrate local lab normal ranges with data extract.
  • Develop QC test plans, perform independent unit testing, complete documentation for SAS code installs and utilize source code management software.
• Project Programming departmental responsibilities
  • Contribute to process improvement initiatives, as agreed to by management.
  • Perform other duties that may be requested by management as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
• Knowledge of programming and validation methods, and software development life cycle.
• Experience with MS Office tools such as MS Word, Excel, and Access.
• Ability to perform multiple tasks efficiently and accurately with minimal supervision while meeting deadlines.
• Ability to work independently and part of the team.
• Ability to learn new programming languages, technology, tools and processes.
• Ability to develop and conduct training sessions, mentor junior staff.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

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

MINIMUM RECRUITMENT STANDARDS:

• Associate degree (or equivalent, based upon education and experience) in life/analytical sciences or related field, and 5 years of work experience in a clinical environment; or
• BS degree (or equivalent, based upon education and experience) in life/analytical sciences or related field, and 4 years of work experience in a clinical environment, or
• Masters-level degree in life/analytical sciences or related field with a minimum of 2 year of work experience in a clinical environment.
• Excellent communication, interpersonal, and organization skills, highly detail-oriented.

CLASSIFICATION:

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

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.