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Senior Data Operation Programmer

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Qualifications:

BSc or above in related discipline, Minimum 2 years' experience in Veeva, Experience in clinical trial environment, Experience developing databases from protocol, Lead experience and EDC experience.

Key responsabilities:

Create and validate clinical trial setup process
Design edit check specifications and implement UAT scripts
Setup and manage configurations for clinical studies
Collaborate with IT and Quality organizations to ensure quality
Track deliverables and evaluate study metrics

PHASTAR Research Large https://phastar.com/

201 - 500 Employees

See more PHASTAR offers

Job description

Overview:

About Phastar

Phastar brings data to life! We are an award-winning specialist biometrics contract research organization (CRO) that works with pharmaceutical, biotechnology and medical device companies to provide statistical consulting, analysis and reporting, data management, and data science services.

Our unique approach to data analysis, “The PHASTAR Discipline”, has gained us a reputation for outstanding quality. With this as our core focus, we’re looking for a talented individual who shares our passion for quality and technical expertise to join our team…could this be you?!

Why Phastar

Phastar is a company that cares. We strive to be the premier biometrics provider to work with, and to work for, and we take our responsibility to do our part for the environment and our community seriously.

Our pro bono scheme provides charities access to our biometrics experts at no cost; we source sustainable products to reduce our carbon footprint and, when you join our team, we will plant a tree in your honour as part of our rewilding project. Learn more about our ESG initiatives at phastar.com/cares.

Caring for YOU

YOUR career, YOUR work/life balance, YOUR PHASTAR experience.

Total flexibility – working hours that work for YOU.
Remote, office or hybrid – a working arrangement that works for YOU.
Culture of learning – continuously develop YOUR knowledge and share YOUR expertise with others.
Career Path - tailored to YOUR strengths and aspirations.
Regular well-being checks – to ensure you get the support you need.
Fun, friendly working environment – experience PHASTAR’s famous social events throughout the year.

Responsibilities:

THE ROLE

Demand for our Functional Service Provision is growing, and we’re looking for talented individuals who share our passion for quality and technical expertise to join our FSP team. All positions can be remote. As a EDC Engineer working within FSP, you will be fully integrated into our sponsor’s team as a key contributor, providing that partner with hands-on technical expertise. Our FSP positions provide the unique opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within a sponsor’s pharmaceutical environment.

Create eCRF specifications, design, develop and validate clinical trial setup process
Create edit check specifications and setup edit checks at trial level
Create and implement UAT scripts to test the setup of the clinical study
Setup different instances of study URL(eg: UAT, production, testing etc.,)
Setup and configure user accounts for study teams
Setup and manage blinded and unblinded study configurations
Be the SME for all database related activities
Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
Knowledge of creating custom functions within EDC systems
Work closely with EDC vendors regarding any tool related issues in the system
Ability to troubleshoot database setup as per study needs
Prepare, test and implement post production changes as per study needs
Archive and retire the study URL after database lock
Partner with appropriate team members to establish technology standards and governance models
Establish and support business process SOPs.
Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
Be a primary change agent to ensure adoption of new capabilities and business process
Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
Work with leaders to resolve issues affecting the delivery of clinical trials
Collaborate with standards team in creating standard CRF libraries for study level consumption
Work closely with data engineers and data management programmers at study level integration and delivery
Lead technology vendor oversight activities.
Be a process expert for operational and oversight models.
Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
Adaptable to new ways of working using technology to accelerate clinical trial setup

Qualifications:

The skills and experience you’ll bring to the role…

BSc or above in Life Sciences, Mathematics, Computer Science or related discipline.
Experience working within life sciences/clinical trial environment.
Minimum 2 years' experience in Veeva.
Build datasets on their own experience and postproduction changes.
Experience developing database from Protocol, experience working with changing Specifications and stringent timelines Have lead experience and EDC experience.