Clinical Data Manager
Publicada en: 15/11/2024
Barcelona Cataluña
Indefinido
Farmacéutica y Asistencia sanitaria
In this role, you will lead and support the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community
Typical Accountabilities
- Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.
- Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices
- Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
- Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.
- Assist with coordination in the Clinical Data management deliverables on assigned projects depending on the relevant model and DM Vendor.
Requirements
- University degree in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject.
- Languages: Fluent English (oral and written) and Spanish.
- At least 2 years of experience should demonstrate full responsibility as a Study Data Manager, or equivalent roles in in a scientific, data-driven position in the medical research area.
- Attention to detail to ensure quality.
- Good verbal and written skills.
- Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines.
- Strong interpersonal skills and proven ability to communicate effectively in a global environment.
Desirable requirements
- Basic understanding of clinical trials methodology.
- Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design and Veeva.