If you are looking to further your professional career in an innovative sector, as part of a highly qualified team where collective talent comes together, Almirall could provide you the perfect opportunity.
Mission
The Clinical Data Lead is responsible for managing and overseeing the data management activities for Almirall’s clinical trials from start up to close out. The selected candidate will work closely with external providers to ensure delivery to time, quality and cost expectations, as well as guaranteeing data management activities according to ICH guidelines, regulatory requirements, and the company’s standard operating procedures (SOP).
Tasks and Responsibilities
* Perform the planning, execution, collection, and interpretation of all clinical data to the highest quality standards (CDISC).
* Report status of clinical data management activities to project teams, CDISC implementation, data standards maintenance collaboration with internal teams and external providers.
* Provide support to the data preparation for reporting clinical study results for regulatory filings, publications, presentations.
* Review on data management documents like coding, protocol, CRF and best practices.
* Contribute to develop and implement data management standard operating procedures.
* Oversight CRO data management outsourced activities, including Data Management Plans, Data Management Manuals, Data Cleaning Plans and Metrics.
* Work with third-party vendors to develop clinical data transfer specifications and databases finalization.
Education
Bachelor in Life Sciences or related field
Specific Knowledge
* Experience in data management activities (e.g., CRF design, CRF annotated review, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, such as WHO and MedDRA).
* Knowledge in data standards, CDISC is the preferred industry standard.
* Data Surveillance methodology and data visualization during the clinical study.
* Clinical data management activities experiences in early and late clinical phases.
* Understanding of applicable international regulations and GCPs.
* Fluent in English is essential.
* Spanish desirable but not essential.
Experience
Minimum experience: 2 years managing clinical trial data in a pharmaceutical, biotech, or CRO setting; dermatology trial experience strongly preferred.
If you are interested in this job offer, please apply below. In Almirall we are committed to diversity by recognizing talent and providing opportunities for all employees present across Europe, as well as in the US.
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