Principal Clinical Data Quality

Principal Responsibilities:

Lead Data Quality Assessor

Responsible for the role which includes planning and execution of data

quality assessments, reporting of the results and archiving of the data

quality assessment documentation. Represents the DMP organization on

one or more study teams as a direct or extended team member. Trains

outsourcing partners, when necessary, and maintains effective

relationships to maximize contribution to data quality activities.

Peer Data Quality Reviewer

Responsible for the role which includes independent peer review of the

data quality assessment results and providing feedback to the Lead Data

Quality Assessor.

AGN Personnel / Subject Matter Expert

Responsible for the role which includes reviewing SOPs, WIs, and other

departmental guidance documents, and identifies opportunities for new

or revised processes to be developed. Participates in meetings,

workshops and seminars to keep abreast of new developments in the

field of DMP and/or biomedical areas relevant to company research

interests. Identifies opportunities to educate peers outside of DMP

Quality in data quality assessment practices, as a means to harmonize

working relationships and promote efficiency. Remains current with

industry trends, best practice, and changing regulatory requirements.

Assesses impact of new regulations and provides feedback. Conducts

process gap analyses and provides feedback to management. Report

potential misconduct during clinical studies to management. Support

Corrective Action and Preventive Action initiatives.

QualificationsQualifications

* Degree or equivalent experience in Clinical Research, Computer Science, Quality

Assurance or related field: 8 years experience, or BS/BA degree with 6 years

experience, or MS degree with 4 years experience.

* Minimum 3 years experience in a project lead role within a clinical data management

organization, preferably within medium-large pharma or CRO.

* Advanced knowledge and understanding of data and documentation related regulations

* Intermediate knowledge and understanding of Clinical Data Management and Clinical Programming

methodologies as well as current and emerging global industry standards

* Advanced knowledge of Research & Development and an understanding of regulatory

guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)

* Intermediate knowledge and understanding of regulatory guidelines for the use of computer systems in

clinical studies

* Advanced knowledge of global standards related to clinical study data management activities (CRF

design, data standards, database design, coding and coding dictionaries, etc.).

* Ability to effectively interact with and influence others without direct reporting relationships

* Ability to multi-task and prioritize

* Planning, organizational, and project management skills

* Attention to detail with high quality outputs

* Negotiation skills

* Conflict management skills

* Computer skills (word processing, spreadsheets, graphics, PowerPoint)

* Ability to travel 5%

To find out more about Real Staffing please visit www.realstaffing.com