DESCRIPTION:
GRIFOLS, a global leader in the biopharmaceutical industry, is offering a Clinical Affairs Data Specialist position focused on ensuring the integrity and quality of clinical trial data through advanced analytical and management solutions.
POSITION OVERVIEW:
The main tasks to be carried out by the IBiDAT project manager include the following:
- Support Clinical Affairs Team in Data Management Workflow
- Collaborate and oversee Data Management Activities of the assigned clinical studies
- Participate in the design of Case Report Forms (CRFs) and data collection workflows based on clinical trial protocols.
- Prepare and Validate Specific Scripts for the Data Workflow
- Design and Validate EDC systems and related databases.
- Supporting Clinical Affairs Specialist in executing Data Workflow so monitoring can be performed
- Supporting internal and external stakeholders in training and managing Data Workflow
- Keep contact with related software providers
- Support Clinical Affairs Team in Statistical Analysis of Clinical Trials
- Prepare and design the statistical approach across the assigned clinical studies
- Execute Statistical Analysis per plan and protocols including validation of functions if applicable
- Prepare statistical related information for regulatory submissions
REQUIREMENTS:
- Bachelor’s degree in Biosciences, Biostatistics, Biotechnology, Pharmacy, Biomedical Sciences or a related field.
- A Master’s degree in Biostatistics, Data Science or a similar discipline will be highly valued.
- 2–3 years of experience in Data Management, Biostatistics or Clinical Data Analysis, ideally within clinical research, diagnostics, pharma or healthcare environments.
- Experience in Medical Devices is a plus but not mandatory.
- Programming knowledge, knowledge in EDC systems and/or database standards. Knowledge of programming languages such as Python, R or SAS is an advantage.
- You are familiar with regulatory standards, quality environments and clinical standards as well (e.g., GCP) and understand the importance of data integrity and traceability in clinical studies.
- You have an analytical mindset and strong problem-solving skills, with the ability to work in a structured and detail-oriented manner.
- You are proactive and flexible.
- You are motivated by implementing new tools and improving data systems and processes.
- Advanced level of English, both spoken and written
JOB CONDITIONS:
- Flexibility for U Program: Hybrid model.
- Flexible schedule: Monday-Thursday 7-10 a 16-19h and Friday 8-15h .
- Benefits package
- Contract of Employment: Permanent position