Robin Fitzpatrick Email & Phone Number

Durham, Nc, Us

In this position, I leverage 20 years of experience to manage Oracle InForm and Electronic Data Capture (EDC) server side software platforms. I also develop software solutions according to internal and external end-user needs. I collaborate with the operations unit and data management team to recommend, design, and implement software solutions. In addition, I ensure adherence to organizational standards and best practices for software platforms as well as maintain software function, troubleshooting, and technical requirements documentation for reference. Further, I utilize my technical knowledge to provide all levels of customer service, providing resolution to queries and complaints.Key Project that I have managed for Duke Clinical Research Institute:**Oversaw multiple clinical trials from a server management perspective and assisted in locking 17**Currently assisting in the migration of three trials to the vendor cloud.

Durham, North Carolina, United States

In this position, I managed internal teams to develop solutions in an EDC-based environment. I collaborated with management to formally review staff performance, instituting methods for improvement. I contributed to protocol based EDC study design, including CRF/edit check implementation, adhering where possible to CDISC/SDTM paradigms, optimizing data management, structure, and delivery. I also conducted study planning meetings to establish an effective flow of information concerning timelines, requirements and constraints, and conducted internal audits to assess quality of deliverables. I consistently maintained open and effective communication channels with vendor liaisons for best outcomes. A few of my Key Accomplishments include:** Managed a staff of 16 clinical database and statistical programmers located in multiple hemispheres.** Brought several trials, implemented in multiple EDC software suites, from CRF/edit check design phase to trial lock. ** Managed individual trial processes, lead each trial to go-live, including integrations, staff, and outside vendors.** Guided maintenance and troubleshooting of live studies.

As Associate Manager of Clinical Database Programming, I coordinated with management, project leadership, and data management leads to create project scopes and objectives as well as provided guidance and support to team members, for improved work productivity. I also determined the scope of technology solutions and the resources required for completion as well as provided technical consultation and product expertise for the delivery of comprehensive solutions.One of my key achievements in this position:**Trained, motivated, and mentored team to maintain the highest company and customer service standards while efficiently performing day-to-day activities.

Durham, North Carolina, United States

As Principal Programmer, I provided technical support and product expertise for programming activities on domestic and international trials. I also created and instituted the procedure to build and maintain the database set-up for web-based EDC in standard format, or Clinical Data Interchange Standards Consortium (CDISC) format including Case Report Form (CRF) design and annotation where applicable. Additionally, I monitored quality control, implementing consistency checks in standard or CDISC format for applicable CDMS and EDC database builds. Further, I built and operationalized processes that ensured timely data-loading and maintained data accuracy and relevance. In this position, one of my Key Achievements was:**Designed and brought five trials to go-live, each in a 10-12 week cycle.

Raleigh, North Carolina, United States

I applied my expertise to manage and enforce budget and timelines in conjunction with the Data Management team. I also developed positive, collaborative relationships with sponsor and Oracle Representatives to discuss and resolve issues that affected Inform software performance. In addition, I managed trial development activities, domestically and globally and annotated information including specifications, database, coding setup and administration, and edit check programming.One of my primary achievements in this position:**Directed multiple project activities, developing, designing, validating, and implementing Inform software solutions that met time, production, and quality specifications. **Built first set of trials that utilized the then new Central Designer programming palette (replacing Architect).

Durham, North Carolina, United States

I served as Lead Programmer for assigned trials, managing the trial development process from inception to go-live. I established positive departmental and inter-departmental relationships, guiding support team members to be efficient in performing activities. I also coordinated with the Data Management team to ensure software performance adhered to established compliance and quality controls. I designed and maintained Inform software, including Cognos reporting, in accordance with standard operating procedures, defined timelines, and project plans as well as evaluated processes, suggesting revisions for increased productivity.One of my key achievements includes:**Designed and brought over 15 trials to go live, managing changes and integrations for each.

Durham, North Carolina, United States

Served as Lead Programmer and developed Customer Defined Database (CDD) for assigned Inform trials; managed rule-programming and trial development process and coordinated activities with Data Management team.

Raleigh-Durham-Chapel Hill Area

Served as Inform Programmer/Lead Programmer for assigned trials; managed rule-programming and trial development process and coordinated activities with Project Manager and Data Management, IT and SAS teams.

Bachelor Of Arts In Political Science, Political Science

Certificate In Applications Programming, Client/Server Program

Master Of Science In Policy Analysis And Management, Policy Analysis And Management

Medical Terminology, Anatomy And Physiology I, And Anatomy And Physiology Ii