Support Clinical Trial Manager at HAL Allergy
The Support Clinical Trial Manager is a contributor to the designs, management and reporting of the Phase I-III clinical trials for the purpose of registration of (new) treatments, extension of the existing indication or to support regulatory or marketing claims. You are accountable for the effective management of the clinical operations, vendor management, oversight of the CRO for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality. You ensure that the assigned clinical study(ies) are run within timelines and budget and are completed in compliance with all relevant regulations and industry guidelines as well as company SOPs. You will work in collaboration with the Clinical Trial Manager, and provide oversight and direction to the internal cross-functional study teams, CROs and the department members for study deliverables.
- Support to design, management and reporting of Phase I-III clinical trials with HAL Allergy products.
- Support to design and implementation of trial management plans, implementation of risk-based monitoring and clinical monitoring models (e.g. on-site and centralized monitoring) into the trial context.
- Leadership of the day to day activities of assigned clinical trials to ensure CRO and study vendors oversight, quality and timely completion per established timelines, goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Day to day risk management and problems/issues solving in the clinical trials.
- Management of the cross-functional study teams including third party vendors (e.g. CRO and central lab) and other collaborators (e.g. investigators, advisory boards, drug safety monitoring boards).
- Acting as internal expert on clinical trials and clinical trial management.
- Contribution to the content of study documents, such as: investigator brochures, clinical study protocol, clinical study report.
- Support the development of study plans (Clinical monitoring plan, study recruitment plan etc) and EDC systems (eCRF, ePRO) set up.
- Contribution to the set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
- Leading the centralized monitoring (if applicable) in the clinical trial context.
- Oversight of the clinical aspects of the data cleaning, review of statistical analysis plan, data analysis and reporting of headline results.
- Conduct co-monitoring visits as part of on-site monitoring, remote data review, conduct of visits to CRO and health/registration authorities.
- Management of study budgets.
- Participation in symposia, international congresses and scientific meetings if applicable.
- Contribution to the preparation and publication of clinical trial data.
- Accountability in the invoicing and site’s payments
- Implementation of appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.
- Leading feasibility assessment and selection of countries and sites for study conduct.
- Involvement in the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
- Participation in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct.
- Oversight and direction to study team members for study deliverables; may provide direction to Clinical Trial Associates, Clinical Data Specialist and Biostatistician for assigned studies.
- Master degree in (bio)medical science.
- Strong experience in Clinical Operations and third party vendor management (CRO, central lab).
- In-depth understanding and experience with the clinical trial process: feasibility, TMF management, start-up, monitoring clinical trials, review of study documents (study protocol and reports) and study archiving.
- Conduct of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
- Strong knowledge of clinical trial guidelines (ICH/GCP, EU CTD, FDA and international regulations).
- Ability to travel as required.
- Collaborative behavior and team player attitude.
- Excellent command of the English language, both verbally as interpersonal, oral and in writing.
- Proficient computer skills including knowledge of MS-Office products such as Excel, Word and Powerpoint.