About the Job

As a Gidy Expert Qualification at Excelya, you will be at the forefront of ensuring compliance and qualification for innovative solutions within the biopharmaceutical landscape. This unique role involves a deep understanding of regulatory standards and the application of best practices in qualification processes.

You will work closely with our teams to design, implement, and optimize qualification protocols that align with our clients' needs and maintain the highest quality and safety standards in their processes.

Main Responsibilities:

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Technical Data Manager, who will be responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

Main Responsibilities:

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 Medical affairs. 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.

Main Responsibilities

• Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
• Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
• Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
• Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
• Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

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.

Main Responsibilities:

1.      Responsible for programming using DMW Oracle and Oracle OAC.

2.     Will design the data model in DMW according to sponsor standards.

3.     Responsible to write data transfer protocol for external data vendors integration from specifications provided by Sponsor

4.     Responsible to manage external data loading and integrations in DMW

5.     Archives Data Management programming documentation. 

Requirements

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: 3 years or more years as OP or equivalent combination of education, training, and experience 

Skills:  

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.

Requirements

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

• 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

About the Job

At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.

As a Clinical Quality Manager, you will lead the development and implementation of quality strategies, manage audits and inspections, and collaborate closely with cross-functional teams to uphold the highest standards in clinical research.

Key Responsibilities

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. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking an Project Data Manager to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.

Main Activities:

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior Quality Engineer in the United States.

We are seeking a seasoned Senior Quality Engineer to support quality assurance efforts in a fast-paced, highly regulated medical device environment. This role will play a key part in ensuring the quality and compliance of software-based products, including those utilizing AI/ML technologies. The ideal candidate will bring deep knowledge of quality standards, risk management, and regulatory compliance, with a proactive approach to continuous improvement and cross-functional collaboration. The position requires experience with software as a medical device (SaMD) and a strong understanding of ISO and FDA regulations.

Accountabilities:

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for an IT Business Systems Manager – Quality Systems in the United States.

As the IT Business Systems Manager for Quality Systems, you will act as the IT System Owner for GxP-regulated platforms such as Learning Management Systems (LMS), Quality Management Systems (QMS), and Electronic Document Management Systems (eDMS). Your role will focus on supporting compliance-related applications and partnering closely with Quality and Validation teams to ensure the successful configuration, validation, and operation of systems like Veeva Vault Quality and ComplianceWire. You’ll lead both technical and regulatory aspects of IT system management in a hybrid agile/waterfall environment, driving scalable and compliant technology solutions.

Accountabilities: