Director - Clinical Data Management
Salary:
$120,000 - $160,000
Our client, a well established international contract research organization serving both commercial as well as government markets, is conducting a search for a Director of Data Management to be based at the company's headquarters in Princeton NJ.
Responsibilities:
Qualifications:
$120,000 - $160,000
Our client, a well established international contract research organization serving both commercial as well as government markets, is conducting a search for a Director of Data Management to be based at the company's headquarters in Princeton NJ.
Responsibilities:
- Lead and oversee data management, EDC programming and validation teams,
- Coach, develop and provide continuous feedback to a team of approximately 10 direct reports/Provide guidance and direction to ensure departmental and client/project goals are met.
- Serve as the lead liaison to internal and external clients, ensures effective resource allocation.
- Develop and track metrics on productivity and quality and creates strategies and best practices to increase efficiency.
- Manage the development and validation of IWRS and EDC study builds and the associated data listings, reports and data transfers and maintains detailed timelines.
- Monitors data management workflow and tracks project metrics for task completion.
- Defines CRF standards, oversees individual study CRF design and production.
- Responsible for the development and approval of standard edit checks and study specific edit checks.
- Oversee the review of clinical trial data to identify erroneous, missing, incomplete, or implausible data.
- Review protocol compliance.
- Approve IWRS set-up for each protocol based on contract terms.
- Approve Data Management Plans and CRF Completion Manuals.
- Responsible for process documentation and training curriculum.
- Develop, revise and review SOPs and WPDs and develop associated training and competency testing.
- Interact with dictionary coding personnel to ensure appropriate process set-up and application.
- Lead weekly cross-departmental status meetings. Effectively allocate resources and lead efforts to agree on solutions.
- Ensure that the team adheres to SOPs and GCP regulations.
- This position requires a limited amount of travel, less than 10%.
Qualifications:
- Bachelor's degree, preferably in a science related field.
- Prior relevant leadership experience inclusive of a minimum of five years of the each of the following proficiencies:
- Managing direct reports and high performing teams.
- Clinical Data Management preferably with oncology experience and understanding of clinical data reporting processes and content.
- Managing EDC study builds/development experience including experience with CDASH.
- Two plus years Oracle Clinical/Remote Data Capture (OC/RDC) experience as well as relational database and report development experience, including basic SQL knowledge.
- Proficiency with web-based EDC systems/Medidata Rave EDC experience preferred.
- Prior experience with IWRS systems preferred.
- Familiarity with data reporting requirements for oncology clinical trials is also preferred.
- Demonstrated knowledge of GCPs, ICH guidelines, CFR Part 11 and computer systems validation.
|
|
 | |
