Ref #: 30019

Employment type: Permanent - Full-Time

Location: Homebased in the United States

Description

Do you have clinical database programming experience and a love for database build? If so, this is the position for you! ICON/DOCS is looking for experienced Database programmer to join their team for this home-based opportunity. Multiple openings available!

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Develop and maintain trial specific Medrio Databases, including eCRF’s, edit Checks and Custom Functions using relevant programming languages (SQL, PL/SQL, C #), of various levels of complexity for Phase I-IV independently.

• Act as a deployment expert in the technical aspects of data management to ensure latest standards are being utilized, current technologies are deployed and system integrations are optimized. At the trial level, driving the use of standards for CRF builds and ensuring best practices are used for edit checks, reports and integrations.

• Partnering with Global Data Managers and Standards experts, where applicable, to evaluate and propose optimal technical solutions to meet protocol requirements and determine implementation plans (e.g., leverage CRO expertise, program internally deploy new system, create new standard) as well as provide hands-on programming as appropriate in support of a trial.

• Responsible for taking a lead role to ensure high level of consistency and quality within and across trials.

• Oversee the technical aspects of CRO database build and maintenance to ensure consistency and standardization across trials.

• This position may lead cross-functional process improvement initiatives or take on a system ownership role.
SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES

( List statements in bullet format )


• Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.

• Read, ensure understanding and adhere to all assigned ICON and/or Sponsor SOPs and working procedures (as appropriate).

• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.

• Complete all assigned trainings and courses in the ICON Training Management system (iLearn) (and / or Sponsor system, as appropriate); ensuring all mandatory courses are completed before the designated date and that the required system specific training has been completed for current studies.

• Record all billable and non-billable time in the appropriate timesheet management system.

• Provides technical solutions for data management deliverables in the data collection capability.

• Provide ongoing support, mentorship and training as appropriate, to members of the team involved in data operations and delivery.

• Collaborate with study teams and serves as the lead on eCRF development, specification and rules programming for a given protocol.

• Ensures eCRF is built according to the latest Janssen standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc.); translate protocol requirements into optimal data capture approaches; either build and deploy a trial in an EDC system or oversee eCRF build and updates by CRO or vendor to confirm quality and consistency with standards.

• Responsible for QC on eCRF Forms/Fields, dynamics (DVRs/CFs), EDC integrations, etc., both on library and trial specific level.

• Creates tSDV technical specifications, Safety Gateway integration specifications and completes the Datamart mapping template.

• Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave.

• Support the development of eCRF standards and drive their implementation within the organization.

• Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.

• Accountable for audit readiness for data acquisition process and documentation.

• Program, or oversee programming of, quality review checks and reports for use by Global Data
Managers and other team members.

• Creates advanced custom programs as per DVS, as required.
• Participates in special projects or tasks as directed by TDA Leader, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.

• To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives.

• To act as a bridge between functions within the TDA group. Addressing technical clarifications and providing guidance as needed.

• Expert knowledge of Clinical Data Standards. Understanding of Data Models and implementation for database deliverables.

• Other responsibilities may be assigned as required.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.