iSTAR Medical SA, founded in 2011 and headquartered in Wavre, Belgium, is a clinical stage, medical technology company focused on the development of novel ophthalmic implants for patients with glaucoma. Glaucoma is the second leading cause of adult blindness globally.
Reporting to the Clinical Operations Senior Manager, the Clinical Scientist will provide scientific expertise throughout the development and implementation of clinical studies.
The Clinical Scientist has the responsibility to:
- Develop, coordinate and/or review clinical evaluation plans, clinical evaluation reports, Summary of Safety and Clinical Performance, risk master lists
- Participate to define the strategy of study (objectives, clinical evidence, countries, recruitment…)
- Develop, coordinate and/or review specific study-related documents (protocol, patient informed consent, monitoring plan, manual of operations, newsletter…)
- Coordinate Data Review and Cleaning activities
- Coordinate Statistical activities (SAP development, statistical analysis, TLFs,…)
- Coordinate Clinical Study Reports development (data base snapshot, medical writing, data interpretation, review,…)
- Manage clinical trial registrations and results postings
- Interact with study team and cross-functional teams (R&D, Marketing, RA) in order to assist in clinical strategy, the development of plans and reports, and project deliverables
- Present at investigator and CRA meetings/training
- Build strong relationship with KOLs and clinical trial investigators
- Support investigators with publications
- Interpret results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
- Interacts with regulatory agencies as needed
- Participates in the development of training and providing feedback and guidance
- Oversight team member specific tasks (in-house CRA and Safety Specialist)
- Support quality control & aassurance activities (Internal QC, CRO & study site audit,…)
As the successful candidate, you have the following profile:
- You own an advanced degree (PhD)
- You have at least 5 years of demonstrated experience in a similar role. Experience with clinical trials is strongly desired.
- You have a comprehensive knowledge of ophthalmology and glaucoma field.
- You have analytical thinking and reasoning skills; Medical writing skills is strongly desired.
- You are thorough and pay attention to detail;
- You are recognised for your Leadership and Project Management capabilities;
- You can communicate effectively; set priorities and you have strong time management skills;
- You are fluent in English, written and spoken. Knowledge of another language is beneficial;
- You are able to use a computer and the main software packages competently ;
- You are a team player with positive constructive attitude to solve problems;
- You are eager to learn, stress resistant and ready to work independently in a start-up environment (hands on);
- You are available to travel around 20% of your time
What do we offer?
We offer a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium (Wavre) with possibility to work from home a few days a week and has an international scope.
Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven tracks records in the pharmaceutical and medical device industries.
We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.
Excited about the role?
To apply, please send your CV and a motivation letter to email@example.com with Reference Clinical_Scientist_2021