Clinical Data Manager (I)

Excelya Group; Bengaluru; Vor Ort; INR 1.200.000 - 2.200.000; Vollzeit

Zusammenfassung

Excelya in Bengaluru, India, seeks a Clinical Data Manager to uphold regulatory standards and Excelya Group SOPs. You will manage data cleaning, review, discrepancy handling, and data reconciliation across studies, collaborating with the Lead Data Manager and contributing to study metrics and archiving.

Ideal candidates have 1+ years as a Data Manager, strong knowledge of ICH GCP, CDM best practices, and experience with clinical trial databases and eCRF design. Fluency in English is required.

Qualifikationen

• Experience as Data Manager or equivalent
• Knowledge of ICH GCP and regulatory guidelines
• Experience with clinical trial databases and CDM processes
• Understanding of study lifecycle (start-up to closeout)
• Proficient with Office suite and data reporting
• Fluent in English

Aufgaben

• Follow Excelya SOPs and regulatory guidelines
• Data cleaning, data review, discrepancy management
• Work with the Lead Data Manager on studies
• Generate study metrics and status reports
• Participate in study documentation archiving
• May participate in EDC database build and testing
• Complete administrative tasks like timesheets and training updates

Kenntnisse

ICH GCP knowledge

CDM best practices

Clinical data flow

eCRF design

Data review

Communication skills

Ausbildung

Bachelor's degree in a scientific discipline

Tools

MS Word

MS Excel

MS PowerPoint

MS Project

Jobbeschreibung

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

Main Responsibilities

• Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation.
• CDMI works under the supervision of more senior staff (Manager or Senior CDM).
• Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.
• Work closely with the Lead Data Manager responsible for the study.
• Generate study metrics and status reports within and across several studies.
• Participate to study documentation archiving.
• May participates in EDC database build and testing through go live.
• Completes Excelya administrative tasks as required e.g., timesheets, CV and training updates.
• May undertake other tasks as they may be assigned from the supervisor that will concern any of the Excelya Group companies

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: One or more years as a 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
  • Understanding of recommended CDM best practices and associated documentation
  • Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
  • Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)
  • Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc).
  • Ability to maintain high level of professionalism, ethics and compliance at all times.
  • Effective verbal and written communication skills
• Education: Bachelor’s degree qualification in a Scientific discipline is preferred
• Languages: Fluency in English

Why Join Us?

At Excelya, we combine passion for science and 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.

Excelling with Care

At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.

Your challenges become our shared mission. Together, we transform bold ideas into reality, the Excelya way.

Watch our testimonial video to hear directly from our Excelyates about why Excelya is more than just a workplace—it’s a community built on values.