Anne Eppinger

About Anne Eppinger

Coordinates efforts in communicating clinical study information for global harmonization within Organon related to data management activities•Evaluate any new information technologies that would enhance the data management process•Determine the needs for technical, supervisory, pr personal training/development for CDM staff and evaluates the feasibility of using an internal or external trainer, and selects the most appropriate on-site consultant or off-site institute for external training course•Managing a staff of ten data management personnel •Creates and maintains databases in the Clinical Data System•Training of Clinical Data Analysts with respect to all data management activities and provides basic technical support with respect to computer programming•Assists in global system enhancement involving data management programs to be implemented across clinical studies using comparable data structures.Specialties: Experienced in CLINTRIAL, SQL, RPL, SAS, Oracle Clinical,Windows,Microsoft Office (Word, Excel, Outlook, & PowerPoint).

Experience

1. Senior Clinical Data Management Project Data Management Services

   Merck

   Jun 1992 — Present · Rahway, NJ, US

   Responsible for day to day operations of Clinical Data Management-Data Quality Control•Responsible and accountable for producing timely and high quality clinical trial deliverables•Lead strategic planning efforts regarding timelines, budget and resources as they relate to data quality control tasks•Implement procedures to monitor the quality of all data control deliverables, whether the trials are performed in-house or external•Provide leadership in data management processes for projects with focus on global action plans, definitions and methods•Evaluate new information technologies for enhancing data management processes and proposed customization of existing processes for the enhancement of global harmonization objectives

Education

• New Jersey Institute of Technology

  Masters of Science Management

  1997

Skills

• Program Management
• 21 Cfr Part 11
• Life Sciences
• Oncology
• Computer System Validation
• Validation
• Lifesciences
• Databases
• Data Management
• Sas
• CRO Management
• Clinical Trials
• Clinical Development
• Pharmaceutical Industry
• Sop
• CRO
• Good Clinical Practice (Gcp)
• Pharmacovigilance
• Inform
• Electronic Data Capture (Edc)
• Ich-Gcp
• Drug Development
• Gcp
• Strategic Planning
• Programming
• Edc
• Therapeutic Areas
• Ctms
• Clinical Study Design
• Clinical Research
• Gxp
• Clinical Data Management
• Oracle Clinical
• Sql
• Management
• Clinical Trial Management System (Ctms)
• Regulatory Submissions
• Cdisc