Database Developer (Rave EDC)

30 Premier Research Group (India) Private Limited; Bengaluru; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Database Developer (Rave EDC) to join our Clinical Data Sciences team in Bengaluru. This hybrid role requires you to work from the Bangalore office and relocate if needed.

You will contribute to eCRF creation, data entry screen design, and database development for clinical studies, collaborating across functions to define the data management plan. The ideal candidate has a Bachelor's degree (or 5 years related experience) and 4 years of clinical database development

Formación

• Bachelor's degree or equivalent; 5 years clinical research/healthcare exposure in lieu of degree.
• 4 years of clinical database development experience required.
• Knowledge of ICH/GCP and regulatory guidelines preferred.

Responsabilidades

• Create electronic Case Report Forms (eCRFs) per finalized protocols.
• Build data entry screens per approved annotated CRFs for paper studies.
• Design, build and test clinical databases per SOPs.
• Program field derivations, edit/consistency checks, and screen flow in CDMS.
• Collaborate with Data Management, Statistician, PM and sponsor to define data management plan elements.
• Produce database documentation including annotated CRFs and TMF retention.

Conocimientos

eCRF design

Data entry screens

Clinical DB development

Derivations & checks

CDMS testing

Documentation

Educación

Bachelor's degree

5 years clinical research experience

Descripción del empleo

Premier Research is looking for a Database Developer (Rave EDC) to join our Clinical Data Sciences 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.

This is a hybrid role based in our Bangalore office. Candidates must be based in Bangalore or willing to relocate and able to work from the Bangalore office as required.

What you’ll be doing

• Creates electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies
• Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
• Designs, builds and tests clinical databases according to Premier Research standard operating procedures
• Programs field derivations, edit/consistency checks, and setup of screen flow in the CDMS for Data Entry
• Works in collaboration with the Data Management project team, Statistician, Project Manager and the sponsor to define all elements of the data management plan
• Writes procedures, validation and data extraction programs
• Produces database documentation including an annotated CRF
• Ensures database documentation is maintained for the Trial Master File
• Works in collaboration with the Data Management project team, Statistician, Project Manager and the sponsor to define all technical elements of the data management plan
• Performs system testing and assists with Quality Control (QC) of specified deliverables
• May assist in maintaining the CDMS global and program libraries
• May be required to undertake programming tasks
• All other projects as assigned

What we are looking for

• Educational Background: Educated to Bachelor's degree level, or equivalent. In lieu of this qualification, 5 years of experience in clinical research, drug development or healthcare environment will be required.
• Experience: 4 Years of clinical database development experience required. Alternatively, must have proven experience in all primary job functions. Clinical trials support or pharmaceutical industry experience preferred.
• Knowledge: Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Expertise and know-how: Has developed understanding of database development processes, SOPs, and working guidelines. Knowledge of ICH / GCP regulations Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures Knowledge of web based communication tools for conferences
• Personal skills & behaviours: Fluent verbal and written English as well as the local language(s) required for clinical trial submissions. Excellent team player, collaborative and able to build an effective team. Ability to multitask and work effectively in a fast-paced environment with changing priorities. Strong verbal and written communication and negotiation skills. Excellent organisational and time-management skills, able prioritise work to meet deadlines. Accountable, dependable and strong commitment. Is customer service focused in approach to work both internally and externally. Maintains a positive, results orientated work environment.

Our Values

We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.