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.
Clinical Data Specialist / Data Manager
Since its foundation 1959, HAL Allergy grew to a well-established player in the AIT market with a highly competitive portfolio offering subcutaneous (SCIT) and sublingual (SLIT) products for pollen, house dust mites and insect venoms. Our GMP certified and state-of-the-art production facility is located in the Bio Science Park in Leiden, The Netherlands.
- 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 reportB) Technical support to the clinical team in in-house and on-site monitoring of clinical trials by HAL Allergy.
- 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 in 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 CRO and other vendors (IVRS/IWRS, diary if applicable) selection 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.
- A bachelor or master degree in a life science or related field of study or equivalent combination of studies and/or work experience.
- 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.
- Good command of the English language, both verbally and in writing. 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) if business needs dictate.
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority.
- This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden, where we work on the full product pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary.
- Bonus scheme
- Lease car allowance
- 30 leave days.
- Company contribution to a pension package and heath insurance.
Who are we looking for?
We are looking for a result orientated, flexible and enthusiastic individual who possessed a considerable amount of knowledge in clinical research. A quick learner who can absorb new ideas and is strong in coordinating, organizing and reporting within a team of motivated colleagues.
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
HAL Allergy, for those who seek for pharmaceutical innovation.
HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient’s well-being is always top of mind. At HAL Allergy, we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become part of an innovative and challenging pharmaceutical manufacturer, then this is a perfect opportunity!
HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.