PROJECT DATA MANAGER
Posted: 7/21/2010
Type: Contract
Length: 12 Months
Location: Northern NJ
Description
Our client is looking for a Project Data Manager within their CNS group for a long term contract.
Specific responsibilities include but are not limited to:
Overseeing all project related Data Management activities such as CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents.
Primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery.
Reviews Data Management performance against established metrics in a Data Management Performance Report, prepared at the conclusion of each study.
Ensures that a complete archive of Data Management documents and records is maintained in accordance with applicable company and regulatory guidelines.
Evaluates contracted regional CROs on an ongoing basis to determine if they fulfill requirements of SOPs (including Working Policies (WPs)), timeliness, and quality.
Evaluates candidate CROs and external vendors as to their ability to adhere to companies SOPs (including WPs), and quality standards before any outsourcing contract is finalized.
Manages database and supporting documentation archival to meet long-term regulatory requirements.
Ensures that all project related outsourcing agreements are comprehensive and complete.
Qualifications:
MS; BS/RN in life sciences
• 6+ years experience as a CDM
•Experience overseeing CRO's
experience with study start up through db lock
• Project management experience preferred
EDC experience (Inform preferred)
CNS experience preferred
Experience with phase 1 studies preferred
To apply, please contact:
Email: job@orbisdata.com
