Technical Data manager

Excelya; Bengaluru; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Excelya, Bengaluru, is seeking a Technical Data Manager to lead CRF design, data validation, and data flow activities in clinical trials. You will collaborate with Data Managers and senior staff to ensure high regulatory standards and accurate data representations throughout the study lifecycle.

The role requires 4+ years in TDM or equivalent, solid knowledge of ICH GCP, and proficiency in EDC systems and Oracle Clinical One.

Qualifications

• Four+ years as Technical Data Manager or equivalent.
• Knowledge of ICH GCP and regulatory guidelines.

Responsabilités

• Design CRF in EDC databases per study specs.
• Maintain global libraries in EDC database.
• Contribute to study documentation and edit checks writing.
• Ensure compliance with Excelya SOPs and QC processes.
• Support data management activities across study lifecycle.

Connaissances

CRF design

Data management

Data validation

Data review

GCP compliance

English communication

JavaScript

Formation

Bachelor's degree in science

Outils

Oracle Clinical One

MS Office

EDC systems

Description du poste

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

The Technical Data Manager is responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

Main Responsibilities

• Responsible for CRF design (Unique) in the EDC database, screens design, Data Validation Plan writing, edit checks programming in EDC database as per the study specifications, and writing listings specifications.
• Work closely with the Data Manager & Lead Data Manager responsible for the study under the supervision of more senior staff (Manager or Senior TDM)..
• Responsible to maintain global libraries in EDC database.
• Participate to study documentation, Maintain the updated documents related to the technical specifications.
• Adherence to the internal technical QC and document updates.

Requirements

• About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Experience:

Four or more years as a Technical Data Manager or equivalent combination of education, training, and experience

Skills:

Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance

Experience in clinical trial databases and applications, clinical data flow, data review, and eCRF Report Form design and Edit checks (Rule) designing as per the specification provided.

Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)and ossociated CDM best practices and documentation

Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc).

Understanding Java Script and programming best practices.

Good Understanding of Oracle Clinical One is a Plus

Effective verbal and written communication skills

Education:

Bachelor’s degree qualification in a Scientific field is preferred

Languages:

Fluency in English

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model - offering full-service, functional service provider, and consulting - enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.