Sr Clinical Data Associate

CTI; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work from home opportunities

Health benefits

Vacation packages

Resumo da oferta

CTI Clinical Trial and Consulting Services in Portugal is seeking an experienced Clinical Data Manager to support data management activities across clinical studies in a GMP-compliant environment. You will review CRFs, ensure data quality, and maintain essential study documentation.

The role involves training CDA staff, refining SOPs, and coordinating with management to implement efficient data workflows under GCP/ICH guidelines. Hybrid work options may be available in this role.

Qualificações

• 3 to 4 years clinical data management experience.
• 2 years relational database experience.
• Bachelor’s Degree or equivalent in biological, behavioral, or computer science.

Responsabilidades

• Conduct pre-entry review of clinical data.
• Review and issue queries for CRF data based on edit checks, review, and sponsor requirements.
• Assist with set-up of data management study files and archiving of study documentation.
• Maintain documentation to support accuracy and integrity of clinical databases.
• Assist in defining workflow and processes for data management.
• Collaborate with management to develop SOPs relating to data management.
• Conduct and direct database development, testing, and validation.
• Carry out activities according to CTI SOPs and GCP/ICH guidelines.

Conhecimentos

Clinical data management

Relational databases

Formação académica

Bachelor’s Degree or equivalent

Descrição da oferta de emprego

What You'll Do:

• Conduct pre-entry review of clinical data

• Review and issue queries for case report form (CRF) data based on automated edit checks, manual review, and sponsor requirements

• Assist with set-up of data management study files and the collection, transfer, and archiving of study documentation and controlled documents

• Maintains all the necessary documentation to support accuracy and integrity of clinical databases

• Assist with the tracking of controlled documents (CRFs, data clarification forms [DCFs], etc)

• Assist in defining workflow and processes for all aspects of data management

• Collaborate with management to develop and refine departmental SOPs relating to data management

• Conduct and direct database development, testing, and validation

• Conduct and direct training of clinical data associate (CDA) staff

• Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Quality Management and Good Clinical Practice (GCP) / ICH guidelines

• Maintain accurate records of all work performed

What You'll Bring:

• 3 to 4 years clinical data management experience in any capacity

• 2 years relational database experience

• Bachelor’s Degree or equivalent in biological, behavioral, or computer science

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.

• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.

• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Please Note

We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process