Clinical Database Developer (Rave EDC)

Premier Research Group; Bengaluru; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Premier Research Group is seeking a Clinical Database Developer (Rave EDC) to join our Clinical Data Sciences team in a hybrid role based in Bangalore. Candidates must be based in Bangalore or willing to relocate and able to work from the Bangalore office as required.

You will create eCRFs and data entry screens, design and test clinical databases, and collaborate with DM, statistics, and project teams to define data management plans.

Qualifications

• Bachelor’s degree or equivalent; 5 years in clinical research, drug development or healthcare required.
• 4 years of clinical database development experience required.
• Clinical trials support or pharma industry experience preferred.
• Knowledge of ICH and local regulatory authority drug research & development regulations.

Responsibilities

• Create electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies.
• Create data entry screens according to the approved annotated CRF for paper studies.
• Design, build and test clinical databases according to Premier Research SOPs.
• Program field derivations, edit/consistency checks, and setup of screen flow in the CDMS for Data Entry.
• Collaborate with Data Management, Statistician, Project Manager and sponsor to define all elements of the data management plan.
• Write procedures, validation and data extraction programs.
• Produce database documentation including an annotated CRF.
• Maintain database documentation for the Trial Master File.
• Collaborate to define all technical elements of the data management plan.
• Perform system testing and assist with Quality Control (QC) of deliverables.
• May assist in maintaining the CDMS global and program libraries.
• May undertake programming tasks.
• All other projects as assigned.

Skills

Rave EDC

Clinical database development

CDMS design

Data extraction programs

SOP knowledge

Education

Bachelor’s degree in Life Sciences / related field

Tools

Rave EDC (Medidata)

Job description

Premier Research is looking for a Clinical 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 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.