Vacancy Clinical Trial Monitor – Brussels
11 SEP ’22: For a global biopharmaceutical company focused on discovery, development and delivery of innovative medicines for patients to overcome serious diseases, we are currently looking for a Clinical Trial Monitor. This role is particularly interesting as you will be the essential link in allowing clinical trials, in the field of oncology, cardiology, immunology and pediatrics, to proceed successful and in accordance with the set rules/regulations.
As Clinical Trial Monitor, you will be responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Besides, in this position you will act as one of the points of contact at a site level for internal and external stakeholders and you will provide trainings to sites. Besides, you will perform site closure activities, manage multiple protocols across multiple therapeutic areas which may require travel and ensure completeness and quality of data. Moreover, as a core focus the Clinical Trial Monitor:
- Identifiesnew potential Investigators,throughongoing collaborations;
- Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials;
- Develop Site relationships and recommends sites during the site feasibility and/or site selection process;
- Conducts pre-study visit, initiation visits and reviews site activities and quality through on-site and off-site visits;
- Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable;
- Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately and promptly escalates serious or persistent outstanding issues to management and project team;
- Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions;
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
As a holder of a Bachelors degree in Life Science with a valid drivers license (locally required) you have 2-3 years relevant clinical research experience. Also, you have experience in drug discovery/development process and basic to good knowledge of ICH/GCP guidelines and applicable local laws.Moreover, you bring along:
- Knowledge and understanding of clinical research processes and methodology;
- Organisation and time management skills;
- Strong verbal and written communication skills in French, Dutch and English;
- Competence in using the following systems: Microsoft Suite, Clinical Trial Management System, Electronic Data Capture System, Electronic Trial Master File, Metric Websites.
You will receive acompany car or car allowance and a health promotion plan (50% reimbursement for sport activities). Besides being part of a pioneer in Life Sciences, more specifically in the world of biotechnology & pharmaceuticals, this organisation offers:
- A competitive base salary tailored to experience;
- A bonus plan of 14%;
- Health insurance;
- Life insurance;
- Accident insurance;
- Pension plan (98% paid by the employer);
- 30 holidays including the option to buy/sell 10 days.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotechnology
+31 6 51 66 69 96