US ~ Miami
Clinical Systems Programmer
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- Responsible for simple/standard eCRF database design tasks (database screens and database edit checks) and providing administrative system support for other members of Database Programming department.
- Responsible for validation of DB builds including generation of validation packages and execution of test cases. This position works with Quotient Sciences programmers to gather all requirements and test them adequately.
Main tasks and responsibilities will include:
- System administration tasks such as setting up user access, data extracts and archiving.
- Designing simple/standard eCRF database screens and database edit checks
- Assisting as directed in aspects of design and testing of clinical study databases
- Ensures training file is up to date.
- Responsible for ensuring that work is conducted in accordance with SOPs and the principles of Good Clinical Practice.
- Undertake other such tasks as might reasonably be requested from time to time by his/her supervisor and to ensure that his/her work is conducted in a co-operative and flexible manner.
- To participate in overtime as is reasonably required to ensure the smooth running of the department.
- Assists with all other duties as assigned.
Other tasks and responsibilities:
- Plays an integral role in Esource trial build as the lead tester.
- All testing should be documented per Quotient Sciences Miami Standard Operating Procedures.
- Develops documents from automated software testing software for validating eSource EDC trials.
- Ensures all changes to the EDC trials are documented in Change Control documents and in accordance with SOP.
- Prepares all validation documentation for approval per Quotient Sciences Miami Standard Operating Procedures.
- Reads each protocol completely and thoroughly and draft the Study Activity Schedule to ensure compliance with and accurate reflection of the protocol. Also responsible to post it on shared drive upon approval.
- Responsible to draft study source documents to ensure compliance with format and data collection practices for each assigned studies. Also responsible for printing and setting up source document binders for each study.
- Collaborate with Data Entry Manager, Clinical Lead and Project Management for sponsor specific requirements and operational considerations while drafting Activity schedules and Paper sources.
- Provides system support to clinical staff on critical PK/intensive procedure days and First dosing days.
- Preferably College Graduate with Bachelors or Associate degree with 1-2 years of programming experience.
- Has some understanding of drafting and executing test cases
- Motivated to work in clinical research environment
- Ability to work to deadlines whilst maintaining quality standards
- Excellent written and verbal skills.
- Highly organized and efficient.
- Attention to detail and the ability to multitask
- Must be flexible with work schedule and be able to work outside of normal business hours to accommodate clinical unit needs, which operates 24/7.
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.