Mark Talbert

  • Dexter US-MI
Mark Talbert

Work History

Work History
Jun 2010 - Present

Senior Data Manager

SDC, Inc.

* Proficient in OC/RDC - Oracle Clinical remote data capture.

* Developing, coordinating, and monitoring the data management process across the assigned team.

* Managing clinical trial data through review, computerization, cleaning, and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, good clinical practices, and regulatory agency guidelines

* Maintaining and developing client communication with regards to data management project status, issues that arise, and completion of tasks within the project

* Developing, testing and maintaining computer edit checks

* Development of case report forms (CRFs)

* SAE reconciliation

* Lab data reconciliation

* Completely 21 CFR Part 11-compliant division;  strict adherence to HIPAA is required;  GCP observed & maintained.

Jul 2008 - Jun 2010

Clinical Data Manager II

i3 Statprobe

* Developing, coordinating, and monitoring the data management process across the assigned team.

* Managing clinical trial data through review, computerization, cleaning, and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, good clinical practices, and regulatory agency guidelines

* Maintaining and developing client communication with regards to data management project status, issues that arise, and completion of tasks within the project

* Continuing to hone public presentation skills via departmental updates across the company

* Developing, testing and maintaining computer edit checks

* Assist with development of care report forms (CRFs)

* SAE reconciliation

* Lab data reconciliation

* Completely 21 CFR Part 11-compliant division;  strict adherence to HIPAA is required;  GCP observed & maintained.

Jun 1998 - Aug 2008

Clinical Data Manager I

i3 Statprobe

* Developed, coordinated, and monitored the data management process across the assigned team.

* Managed clinical trial data through review, computerization, cleaning, and auditing of data and databases in compliance with standard operating procedures, client guidelines, good clinical practices, and regulatory agency guidelines

* Maintained client communication with regards to data management project status

* Completely 21 CFR Part 11-compliant division;  strict adherence to HIPAA was required;  GCP observed & maintained.

Education

Education
1986 - 1990

BA

Skills

Skills

Project Management Skills

Although I am not a Project Manager within my company, my job entails many aspects of project management, and I have been named the "lead" on several projects that have allowed me to stretch my project management wings.  Because I was not hired directly as a PM, my growth trajectory has been slower than otherwise, but my manager has been modeling and coaching me in strong PM-skills for the client-projects to which I've been assigned.

ePower Desktop Express 6.1

ePower Desktop Express is a storage center for data sources that my company uses on a daily basis.  The modules allow us to scan CRFs to be used for data entry purposes across sites.  It allows us to have data readily accessible throughout the company for in-house and client use (via Knowledge Port).  I work with this system daily and have mastered many different aspects of it, to the point that my coworkers often seek my advice and expertise to accomplish their goals within ePower.

Adobe Acrobat 6.0 Professional

In my current position, we do more that just open PDF documents; we create them, edit them, and use Acrobat in its full scope and intention.

Microsoft Office Suite

My company currently uses MS Office 2003, which includes the Word, PowerPoint, and Excel modules.  I work within these programs on a daily basis, am comfortable with all aspects of them, and have mastered their useage.

SAS 8.2

I have worked in SAS since I began working in the field of clinical data management.  Through the years I have done data entry in SAS, but have also progressed to tweaking programs written by the programming department for our various clinical trials and studies.  I do not do straight SAS programming, but am versatile and completely competent within the programming format to complete my tasks and other challenges that might arise during my work week.

Oracle Clinical 4.5

I have been working in and with OC in its various incarnations for the past 10+ years.  I have done everything including tweaking programs in OC, but do not consider myself an OC programmer.   I am incredibly efficient within the program and work with it on a daily basis.

Interest

When I'm not working, I enjoy spending time with my family, am involved in my community, and am actively involved in our church.

Objective

I am always interested new and creative ways to stretch myself; my skills are top-notch within my field of Clinical Data Mangagement, but I always strive to improve, to better meet my clients' needs, and to learn new ways to excel in my field.