Clinical Data Manager

Company: Integrated Resources, Inc ( IRI )
Location: Oklahoma City
Posted on: May 14, 2022

Job Description:

ACCOUNTABILITIES:
Candidate should have prior experience with either clinical sample tracking or biobanking LIMS systems or clinical data and have a solid technical understanding of integration features particularly around data flow.
Technical knowledge to maintain and transfer electronic files through sFTP, APIs etc.
Provides guidance and oversees data flow from internal and external data platforms.
Experience in regulatory and quality standards around data requirements.
An understanding of biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.), and the types of data generated from such platforms, is highly desirable.
Familiarity and experience with handling clinical data sets, clinical data standards (e.g., CDISC, SDTM) and related industry standards.
Self-motivated
Highly organized, highly detail-oriented, able to excel in a matrix team environment, with superior written and verbal communication skills.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MS with 3+ years' experience, or BS with 5+ years' experience. Pharmaceutical / Biotech industry experience required.
Strong working knowledge of clinical operations and how data flow occurs as part of an industry-sponsored clinical trial.
Expert communication skills: ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority.
Broad and strong network in the industry, biotech, CRO communities, and health authorities.
Have a strong understanding of the clinical trial sample and data lifecycle.

Keywords: Integrated Resources, Inc ( IRI ), Oklahoma City , Clinical Data Manager, Executive , Oklahoma City, Oklahoma