Clinical Data Manager (I)

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. 

·       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

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

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.