Experience

Synteract

• United States
• Biotechnology Research
• 100 - 200 Employee

• Principal Clinical Programmer

  • Apr 2018 - Present

• Senior Clinical Programmer

  • Jan 2016 - Mar 2018



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Clinical Programming

  • May 2010 - Dec 2015

  • Manage a group of seven clinical programmers.• Resource planning for project and time management.• Manages study level metrics, progress, and status, including large programs of studies for key sponsors.• Ensures project timelines and scope of work are achieved as on-time, high quality deliveries.• Ensures high quality deliverables at site-level by providing senior review of core deliveries for accuracy, performing in-progress audits, and attending sponsor audits.• Serve as Lead programmer on multiple clinical trials including planning, conducting, validating, and maintaining the design and development phases• Review of CRF annotation, database and data entry system development, data validation, auto encoding, and certain clinical reports.• Mentoring and training team members, providing coaching as needed in order to help develop their skills.• Creation and Review of work instructions, SOP’s and department process• Maintains departmental site-level utilization/realization and project-level targets at a profitable level.

• Database Programmer II

  • Aug 2006 - Apr 2010

  • Created entry screens and edit checks (in compliance with the Data Validation Plan) in multiple CDM systems ( Trialbase V4.2, Oracle Clinical RDC 4.5.3, Clintrial) • Validated/performed quality control on databases and programs, ensured that output meets quality standards and project requirements, document and communicated findings to programmer. • Reviewed draft case report forms (CRFs) and provided feedback to the project team which reflected forethought and reduced inefficiencies in programming and database design.• Programmed database listings for internal and external use (SAS 9.2)• Monitored progress on project programming deliverables against agreed upon goals and keep management informed of accurate time estimates for completion of work.• Maintained organized, complete and up-to-date study documentation, testing and validation/quality control documents and programs in compliance with Kendle and sponsor standards.• Contributed to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work and providing feedback or guiding new associates in processes.

• Database Programmer I

  • Oct 2004 - Aug 2006

  • Created data entry screens and edit checks according to the database specification documents on specific data management system (Trialbase 4.2)• Validation and quality control of database setup and edit checks• Annotated CRFs/eCRFs• Reviewed and provided feedback on CRF development. • Participated on the extraction of data and mapping on appropriate statistical system (SAS 9.2). • Programmed database listings for internal and external use (SAS 9.2). • Developed routine project specific applications to support the processes of Database Programming or other functional units (e.g. administrative tools) according to project requirements.



Transdigit

• Systems Advisor

  • Jun 2001 - Oct 2004

  • Program and development of autosist system (ERP) from character environment (bbx4) to object oriented (Visual pro 5)• Development of ad-hoc programs according to specific client needs. • Installation and setup of server (Linux Red Hat)• Initial setup of autosist including: configuration, data load, creation of master records, user testing and user training. • On-site support and maintenance of autosist system. • Program and development of autosist system (ERP) from character environment (bbx4) to object oriented (Visual pro 5)• Development of ad-hoc programs according to specific client needs. • Installation and setup of server (Linux Red Hat)• Initial setup of autosist including: configuration, data load, creation of master records, user testing and user training. • On-site support and maintenance of autosist system.