Premier Research is looking for a Database Developer (3 Months - Fixed Term Contract) - India to join our Functional Services Provider (FSP) team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Responsible for the configuration of project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms for the purposes of capturing accurate clinical trial data.
What You'll Be Doing:
- Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design
- specifications for Electronic Data Capture (EDC) studies
- Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper
- studies
- Communicates with data management and study management teams throughout all study start up
- activities to ensure team needs are understood and met.
- Designs, builds and tests clinical databases according to Standard Operating Procedures (SOPs)
- Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
- Writes data extraction programs
- Develops study reporting environment which includes CRF and non-CRF (loaded) data in addition to
- transforming collected data to required reporting format.
- Produces database documentation including an annotated CRF
- Ensures database documentation is maintained for the Trial Master File (TMF)
- Works in collaboration with the sponsor and study team to define all technical elements of the Data
- Management Plan
- Performs system testing and Quality Control (QC) of specified deliverables
- May assist in maintaining the Clinical Data Management Systems global and program libraries
- May be required to undertake additional programming tasks as needed
- May be required to participate in a flexible coverage schedule based on business need
- Performs additional duties as assigned
What We Are Searching For:
- Bachelor's degree, or international equivalent from an accredited institution, preferably in a technical
- field, or equivalent combination of education, training and experience
- 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC
- products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven
- experience in all primary job functions.
- 1 to 2 years of SQL programming experience preferred
- Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership ·
- Demonstrates excellent English verbal and written communication skills
- Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities