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Director, Clinical Data Management

GCE Solutions


Location:
Bloomington, Illinois
Date:
09/25/2017
2017-09-252017-10-25
Job Type:
Employee
Categories:
  • Clinical Operations
GCE Solutions
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Job Details

We are currently looking to strengthen our senior management structure and are seeking a Director, Clinical Data Management to be based in our Bloomington, IL office or home based within US.

Responsibilities:

Lead and oversee Clinical data management function, EDC programming and validation team in the U.S. and U.K. P rovide leadership within Data Management by collaborating with internal and external stakeholders to optimize Data Management technology, processes, and standards Responsibility to strengthen and enhance the DM service, operations, and execution within the function.

We are seeking an experienced professional with a background in biomedical sciences, Data management to help shape and operationalize a long-term vision. Looking for a for a creative, resourceful, integrative thinker for a highly visible role that is responsible for leadership and direction for  DM function

Coach, develop and provide continuous feedback to a team of 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.

Responsible for overseeing all DM activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: project management, Biostatistics and programming.

Ensures that standards are applied across studies (EDC Builds, CRFs, CRF Completion Manuals, Edit Checks, etc.)

Identifies ways to continuously improve all aspects of DM; implements solutions. 

Manage the development and validation of IWRS and EDC study builds and the associated data listings, reports, data transfers and detailed timelines

Monitors data management workflow and tracks project metric

Defines CRF standards, oversees individual study CRF design and production

Experience/skills required:

This position requires experience in diverse therapeutic areas and significant knowledge of Electronic Data Capture/related applications and industry standards, and significant skills in working with data received from Clients and other third party vendors.

This position needs solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines, geographies, and cultures.

This position leverages interpersonal skills and extensive clinical trials experience to mentor/coach within Data Management and cross-functionally.

Possess advanced knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and actively participates in regulatory submissions and inspections.

Skills in continuous improvement, project management, change management, and risk management.

Minimum of Bachelor’s degree, preferably in a Bioscience related field.

Prior relevant leadership experience inclusive of a minimum of five years of the each of the following proficiencies:

4+ years of 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

A minimum of one year 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

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

Company Description:

We are GCE Solutions, a global CRO and solutions provider, supporting majority of large Pharmaceutical organizations, supporting different studies at our clients in different phases. We are in business since March, 2006. We started from Alpharetta, GA and then expanded to multiple locations in US. We are currently having multiple Global locations in USA, Europe (Switzerland), India and Latin America (Mexico).

We are recognized & respect for our QUALITY & EXPERIENCE from our clients.

For more information, please visit our website:  www.gcesolutions.com

Please feel free to reach out to me @ 309-807-1423 for more details OR please share your profile at ashu.bansal@gcesolutions.com

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