LinkedInErika Horan

Erika Horan

Clinical Data Sciences Manager at Endocyte

Location
Indianapolis, Indiana Area
Industry
Pharmaceuticals
Current
  1. Endocyte
Previous
  1. PharmaNet/i3,
  2. Eli Lilly and Company,
  3. Covance Laboratories
Education
  1. University of Notre Dame
362connections

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362connections
Endocyte

Endocyte

Clinical Data Associate IV

– Present

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Background

Summary

Subject Matter Expert: Data Management Process, Oncology, Data Standards

Strong understanding of data management applications including Clintrial, InForm, iReview and SAS

Excellent Project Management skills

Sharp focus on quality and customer service

Influential and respected among colleagues

Effective verbal and written communication skills

Analytical and detail-oriented, resolution-driven

Efficient recognition and pursuit of process improvements

Experience

Clinical Data Associate IV

Endocyte
– Present (2 years 10 months)Indianapolis, Indiana Area

Principal Clinical Data Manager

PharmaNet/i3
(3 years 4 months)

 Managing projects and the necessary resources for successful execution
 Serving as mentor and trainer in all processes within Data Management team
 Training data management personnel in following GCP guidelines, standards, procedures and establishing good working practices
 Assisting in development of departmental policies and procedures
 Maintaining effective collaboration among colleagues to ensure implementation of consistent business practices
 Overseeing data management operations on assigned projects and providing training of data management personnel
 Ensuring activities and processes performed are conducted according to i3 and sponsor requirements adhering to laws and regulations governing clinical data
 Consulting and collaborating with both peer and sponsor study teams and technical functions
 Responsible for creating, reviewing, approving and maintaining all required trial data management documentation
 Creating CRF completion guidelines and presenting at investigator meetings
 Participating in internal and external audits

Data Manager

Eli Lilly and Company
(8 years)

 Coordinating clinical data management processes in Phase I, II, and III oncology clinical trials
 Leading the Study Development Process for trial start-ups including form design, implementation of data standards, system testing
 Developing Data Management Plans, Data Validation Plans, CRF Instructions, electronic edits
 Performing thorough data review to ensure data is logical and of high quality
 Providing oversight and support for global external vendors and monitoring the progress of outsourced data management processes
 Liaising with physicians, statisticians, pharmacists, health outcomes scientists, and CRAs to ensure appropriate data collection strategy and data accuracy
 Reconciling safety and laboratory data with the peripheral databases
 Coordinating all data lock activities

Project Manager

Covance Laboratories
(1 year 10 months)

 Functioning as the primary liaison between Covance and pharmaceutical companies, referral laboratories, and investigator sites
 Managing the laboratory segment of global drug-development protocols
 Designing laboratory specification and logistical documents
 Proactively monitoring studies to ensure accuracy of data

Account Manager

Boehringer Mannheim
(4 years 1 month)

 Providing excellent customer service and technical support for accounts
 Organizing and implementing sales strategy for diagnostic product placement
 Increasing sales in current accounts and prospecting for new business

Skills

  • Clinical Data Management
  • Inform
  • Data Management
  • Clinical Trials
  • Oncology
  • EDC
  • Clinical Research
  • Data Validation
  • Clinical Trial...
  • CRF design
  • CDISC
  • Protocol
  • GCP
  • Oracle Clinical
  • CRO
  • ICH-GCP
  • CTMS
  • See 2+  See less

Education

University of Notre Dame

BS, Science-Business

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