FierceBiotech and FiercePharma Jobs
Associate Director Data Management - verna scientific
Nov 12
Location: Branchburg, NJCategories: Clinical
Website: http://www.vernascientific.com
Position Description
Urgent requirement for one of our top clients located in “Branchburg, NJ”.
Please contact me at your earliest convenience, along with job No. ADDM_111108 to glenn.davis@vernascientific.com
Description:
Manage data management activities related to drug product development for assigned compounds or indications. Collaborate with internal biostatistics, Clinical Operations, and CRO data management and biostatistics. Define and implement data standards across compounds. Collaborate with Biostatistics and Clinical Operations on standardization of database design, edit checks, data review and data extracts. Review published CRFs and hyperlinks in support of FDA, EMEA or worldwide submissions. Review data definition files and other DM or biostatistical components of a submission to ensure content meets Regulatory agency submission requirements. Support development and implementation of EDC systems.
Requirement:
B.S. required, MS prefered. Preference in science or computers. Ten years experience in clinical trials in a data management role. Excellent communication and writing skills
Experience with cancer clinical trials preferred. Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management required. Knowledge of EDC and CDISC required.
Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must) to glenn.davis@vernascientific.com
Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.
