We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
What your responsibilities will be
* Support Clinical Affairs Team in Data Management Workflow
o Collaborate and oversee Data Management Activities of the assigned clinical studies
o Participate in the design of Case Report Forms (CRFs) and data collection workflows based on clinical trial protocols.
o Prepare and Validate Specific Scripts for the Data Workflow
o Design and Validate EDC systems and related databases.
o Supporting Clinical Affairs Specialist in executing Data Workflow so monitoring can be performed
o Supporting internal and external stakeholders in training and managing Data Workflow
o Keep contact with related software providers
* Support Clinical Affairs Team in Statistical Analysis of Clinical Trials
o Prepare and design the statistical approach across the assigned clinical studies
o Execute Statistical Analysis per plan and protocols including validation of functions if applicable
o Prepare statistical related information for regulatory submissions
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* 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.
* You bring 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.
* You have 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
Benefits package
Flexibility for U Program: Hybrid model.
Contract of Employment: Permanent position.
Grifols is an equal opportunity employer.
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