Senior/Lead Clinical Database Programmer

hace 1 semana

Madrid, Madrid, España Pivotal A tiempo completo

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Senior/Lead Clinical Database Programmer who shares our vision of providing clinical research excellence.

Joining Pivotal as a Senior/Lead Clinical Database Programmer means that you'll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You'll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

  • are passionate and fully committed with medical science while using technology, to make a positive impact
  • provide an exceptional experience. We take care of our employees, and we ensure everyone receives permanent mentoring and training and a push to always take one step further as well as untold international experience that will help you grow and will accompany all your life
  • are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives being able to create a place where everyone feels like they belong

Your responsibilities will include:

Design of data collection forms and data validation checks within an electronic data capture (EDC) system for conducting clinical trials. Coordinate tasks and resource allocation for a given project under the supervision of management. Develop training materials and assist with the development of data collection work practices as needed.

Interpret the study protocol for design in EDC

Create study build timeline with input from internal and sponsor teams

Plan and conduct internal and sponsor team meetings for determining data collection requirements and for review of study designs

Design and update data collection forms based on study protocol requirements, corporate standards, best practices (CDASH format), and feedback from internal and sponsor study teams

Create and update data validation edit check specifications based on study protocol requirements, corporate standards, best practices, and feedback from internal and sponsor teams

Program edit checks and custom function

Data import from external data bases

Transfer data into SAS from the different EDC systems

Reports and metrics preparation

Deploy study design to test and production environments

Communicate any project risks to the project manager, including the potential for missing a planned timeline and working outside of the original budget or scope-of-work expectations

Escalate potential quality issues to management

Comply with all training and standard operating procedures (SOPs) for the position.

Handle multiple study design projects simultaneously

Work on projects across multiple trial EDC platforms

Identify areas for process improvement and actively participate in process improvement initiatives as assigned by manager

Train and support junior database programmers to ensure they have necessary skills to meet their deliverable

Support and develop standards ensuring alignment with other functional groups associated with EDC workspace

Requirements:

  • Bachelor's degree in computer or biological/life sciences
  • 5 years of work experience as senior/lead EDC programmer
  • Experience with web page and database design preferred

Experience and accreditation in Medidata Rave, Zelta, Medrio, or Oracle will be considered an added advantage.

Knowledge, Skills and Abilities:

  • Knowledge of clinical research process and methodology.
  • Knowledge and understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
  • Knowledge of CDASH/SDTM standards and mapping
  • Ability to supervise resources and plan tasks for EDC development with the support of management.
  • Ability to work creatively and independently to carry out assignments of a complex nature.
  • Ability to manage multiple project timelines and regularly switch between projects as required to meet timeline deliverable expectations.

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