Senior CDM at Excelya

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Management, Data Cleaning, Data Review, Discrepancy Management, Data Reconciliation, Clinical Trials, EDC Database, Study Documentation, ICH GCP, Regulatory Compliance, Clinical Data Flow, eCase Report Form Design, Study Lifecycle, Effective Communication, Team Collaboration, Oversight

Industry

Pharmaceutical Manufacturing

Description

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 Bangalore. 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 Senior Clinical Data Manager is responsible for performing Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs. Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned As Senior Clinical Data Manager, he/she is responsible for performing Data Management tasks per client work orders to high regulatory standards and Client SOPs. Main Responsibilities: Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation. 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 participate in EDC database build and testing through go live. Senior CDM may act as a Lead Data Manager on local or simple studies Senior CDM provides oversight for more junior staff 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: Five 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 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) Education: Bachelor’s degree qualification in a Scientific discipline is preferred Languages: Fluent in English (written and spoken), Effective verbal and written communication skills . 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 means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission. 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. Apply today, become an Excelyate!

Responsibilities

The Senior Clinical Data Manager is responsible for performing data management tasks per client work orders to high regulatory standards and Excelya Group SOPs. This includes data cleaning, data review, discrepancy management, and data reconciliation activities on assigned studies.