Clinical Science Strategist, Oncology (Home-Based) - IQVIA Biotech (R1100655) in Morrisville, NC at IQVIA™

Date Posted: 11/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    11/7/2019
  • Job ID:
    R1100655

Job Description

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.

IQVIA Biotech is seeking a Clinical Science Strategist with extensive knowledge in Oncology clinical trials to oversee and ensure effective data review. A successful candidate in this role will have more than seven years of clinical research experience and a solid understanding of the processes around collecting and cleaning clinical trial data.

BASIC FUNCTIONS:

Provides support and guidance to operational departments and project teams related to data cleaning. Provides feedback on data cleaning strategies, data collection and review, and other activities relevant to data cleaning of clinical trials to both the internal study team and the Sponsor.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Authors the Data Oversight and Strategy (DOS) Plan, establishes and leads a DOS Team and runs timely data-focused meetings according to the DOS Plan. This includes kick-off and routine meetings, interacting with company and Sponsor attendees, and presenting data issues for review, discussion, documentation and follow-up;
  • Ensures understanding and alignment of Sponsor expectations related to data review;
  • Oversees data review for assigned studies and ensures all data are fully evaluated according to the data review plan within data management. This includes interacting with the study team members responsible for data review (e.g., Data Management, Clinical, Biostatistics) to ensure that data review tasks are occurring per the study plans;
  • Reviews study data to ensure accuracy, consistency and fitness for analysis using available tools (e.g. raw data sets in Excel, programs listings, and/or data visualization);
  • Interacts with the study team across all stages of the trial, from start-up to clinical study report;
  • Attends team meetings.  Participates in project Alignment, Take-off, Data Review and ad-hoc client meetings in support of the project team;
  • Drives process improvement. While on studies, identifies gaps in processes and works to improve those processes both at the study and at the company level;
  • Supports the Project Manager and Clinical Trial Manager in defining and creating a plan to mitigate clinical risk, including but not limited to risk-based monitoring plans and data review plans;
  • Supports and uses the Data Visualization Platform if utilized in a study;
  • Maintains current knowledge of regulations, and guidelines appropriate for functioning in this capacity;
  • Performs other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Ability to manage across multiple clinical trials in a global environment;
  • Experience with protocol design, development strategy and advisory boards;
  • Comprehensive knowledge of Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) requirements; ICH GCP, and international regulations; and FDA guidelines;
  • Strong interpersonal skills;
  • Ability to educate others.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties;
  • Ability to travel domestically and internationally as required.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s degree
  • 7 years of relevant experience working in clinical research; excellent working knowledge of data review and cleaning activities
  • Equivalent combination of education, training and experience

CLASSIFICATION:

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

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.



Job ID: R1100655