Clinical Data specialist at HAL Allergy
The Clinical Data specialist (CDS) is involved in data management processes of clinical trials: set-up of the clinical database, data capture, data cleaning and database lock. The CDS provides technical support to the clinical team for ongoing in-house and in demand on-site monitoring of Phase I-IV clinical trials to ensure Sponsor's oversight of the CRO performance and to ensure compliance to ICH-GCP standards, applicable local regulations and Standard Operating Procedures (SOPs). The CDS will be part of the HAL clinical trial team(s) and acts mainly providing guidelines to the data management and the clinical operation teams of the CRO contracted by HAL Allergy BV. The CDS is also involved in the planning of data management activities, the improvement of internal organizational processes and company’s SOPs.
- Ensure oversight of Clinical Trials in two major areas:A. Ensures integrity of clinical trial data in different processes: planning databases, data cleaning and data reconciliation, including production and QC of clinical data outcomes for the final study report.B. Technical support to the clinical team in in-house and on-site monitoring of clinical trials.
- Develops / reviews DM plans.
- Involved in the design, the review and the testing of the clinical database.
- Develops / reviews programmed and manual edit checks intended to identify and clean up discrepancies in the data entry.
- Organizes and performs data coding reviews, progress reports and data reconciliation.
- Provides operational support to the Clinical Trail Manager in data cleaning activities upon study database lock, verifies integrity of data collected from different study vendors.
- Designs/reviews forms for receiving, processing, or tracking data.
- Ensures study data collection processes adhere to the study protocol, regulatory and ethical requirements, ICH-GCP regulations and Standard Operating Procedures.
- Assess the data collected at clinical sites by the responsible personnel on an ongoing basis.
- Involvement into data collection initiatives to verify protocol compliance and quality of collected data and prepares appropriate intervention plans for the avoidance of errors and deviations from the protocol.
- Involvement in selection of CRO and other vendors (IVRS/IWRS, diary if applicable) as subject-matter expert.
- Training of the CRO/vendor/sites and site research personnel on technical data management processes or software program usage.
- Ensures integrity of the locked data, collaborates with biostatistician on production of study outputs, QC of TLFs together with clinical and biostatistics teams.
- Provide assistance to pharmacovigilance, biostatistician and/or clinical trial manager with project or study related data collection/data interpretation activities.
- Bachelor or master degree in life sciences or related field of study.
- At least 2 years of experience as clinical data coordinator.
- Experience in data management in start-up, maintenance and close-out of clinical trials.
- Experience in the development of study-related documents.
- In-depth knowledge of regulatory context, ICH-GCP and local regulations, as applicable.
- Knowledge of Medidata Rave, Oracle Clinical. Knowledge of SAS is an advantage.
- Excellent command of the English language, proficiency in Dutch is an advantage.
- Proficiency in the use of the Microsoft Office Suite and specialized software for electronic databases.
- This position may require to travel internationally (occasional travels).
Personal and professional skills
You are a result oriented professional that takes accountability for own tasks and actions. You seek cooperation with colleagues and departments within the organisation and with stakeholders outside the organization. You are able to adapt to a dynamic environment.