Jobs Companies Excelya Clinical Data Manager I

À propos de ce poste Clinical Data Manager I chez Excelya

Excelya · Sur site · Bengaluru, Karnataka, India

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

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: 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

Benefits

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.

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.

Apply today, become an Excelyate!

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À propos de Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

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