Senior Clinical Data Manager

Pennsylvania  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Minimum 5 - 7 years experience. Knowledge of Oncology trials desired.

Responsibilities will include, but are not limited to:

Manage clinical trial databases:
Review synopsis and attend Synopsis Review Committee (SRC) meeting
Review protocols for proper data capture including Case
Report Form (CRF) design and CRF completion guidelines
Design eCRF specifications according to the protocol

* Develop eCRF guidelines according to design of the eCRF
* Lead eCRF development until finalization along with Study Team members
* Assigned to more complex studies
* Lead in the development of a Data Management Plan (DMP), when applicable, that outlines CRF flow, data queries, manual checks, and data listings needed to facilitate data cleaning in accordance to our Comprehensive Data Review Plan (CDRP)
* Develop and test edit specifications
* Develop scripts for UAT as well as perform/coordinate UAT testing
* Work with other DM personnel to create, test and implement data edit checks and data listings
* Generate data query forms to be resolved at investigational sites, when applicable
* Ensure coding has been performed and reviewed by Medical Coder
* Perform external data reconciliation
* Provide specific data listings as required by the medical group and review when necessary
* Make data, including interim data, available to company personnel and to regulatory agencies when required
* Trouble-shoot database issues with DBA until resolution is obtained
* Perform database lock and freeze activities
* Prepare/present at Investigator Meetings

Skills/Knowledge Required:

* BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a lead data manager in a pharmaceutical/CRO setting
* Proficient knowledge of EDC databases, preferably InForm and/or Medidata RAVE. Knowledge of Oracle Clinical is a plus.
* Basic knowledge of budget forecasting
* Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
* Proficiency in regulatory guidelines, agencies, GCP
* Advanced knowledge of clinical trial process and data management process

To find out more about Real please visit www.realstaffing.com
Start date
04/2014
Duration
12 months
From
Real Staffing
Published at
27.03.2014
Project ID:
685271
Contract type
Freelance
To apply to this project you must log in.
Register