Trainee Clinical Affairs
Because we are convinced of the win-win opportunities, Qserve offers young academics a diving board to a clinical career in the medical device industry. Your recent knowledge and motivation are of value to improve our products and services. And we are enthusiastic to guide you on the steep learning curve to become a professional in our challenging work field.
In 2021, Qserve starts with a trainee program for young professionals who want to develop themselves in Clinical Affairs. You also get more insight into the regulatory field of medical devices while we train you as a medical writer of clinical evaluations; post-market clinical study plans or submission documents for clinical trials.
You will learn the trick of the trade of being a Clinical professional in a group of trainees, who like you recently finished their Master thesis or PhD. Inspiring mentors with years of experience in the work field of medical devices and clinical research will guide you through a program of face-to-face and online introduction training, on the job training and peer coaching.
Does this sound like the job for you? Then Qserve, a growing organization with a lot of freedom, a high level of exposure and a steep learning curve, is looking for you:
Clinical Affairs Trainees with an affinity for literature, research and clinical trial support.
This is what you will be doing at Qserve:
As a Trainee Clinical Affairs at our company, you provide support to our clients in the medical device industry by conducting literature searches and (re)writing of clinical documentation based on regulatory requirements (EU MDR, FDA). This includes clinical evaluation plans and reports (CEP and CER under the MDR; PEP and PER under the IVDR), post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports, periodic safety update reports (PSUR) and summaries of clinical safety and performance (SSCP).
In collaboration with our clinical operations team (Qserve’s contract research organization), you will help write clinical investigation plans (CIP)and reports (CIR) and all documentation required for clinical studies including investigators brochures (IB), informed consent forms (ICF), case report forms (CRF), data management plans (DMP), statistical analysis plans (SAP) and clinical data analysis and evaluation.
Depending on your background you may also be asked to contribute to the development of surveys to medical device users including the development of the survey questions, plans for execution and analysis and reporting of results.
Also, you can assist our clients with developing investigator newsletters, promotional materials, and training slide decks in support of their studies. You will ensure accuracy and consistency across all clinical content. In cases where the data is collected under a Clinical Investigation Plan, you will contribute to developing the clinical study documentation. Writing clinical reports will become your key competence!
And this is what you will bring:
The ideal candidate has a:
- Recently obtained a technical or scientific degree (MSc or PhD) in (bio)chemistry, (medical) biology, biomedical engineering or biomedical technology or similar.
- Maximum of two years experience in the medical or health-care industry.
- An affinity with regulatory requirements for medical devices / IVDs is preferred.
- Some experience with survey question development, survey planning, execution, data analysis and reporting is welcome.
- Experience with biostatistics including statistical justifications, sample size determination and statistical analysis is an advantage.
- Strong analytical and writing skills.
- Ability to work in small teams with high individual exposure and responsibility.
- Fluent in English.
Qserve is constantly looking for professionals at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, clinical trials or auditing in the area of medical devices and in vitro diagnostic devices. We are a worldwide operating and fast-growing regulatory consulting and CRO organization in the medical device sector with our largest base in Europe, and local teams in China and the USA.
Is this your DNA?
Do you find pride
in supporting customers in line with professional
and ethical values
? Do you have a practical approach
and like being creative
in finding solutions? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!
Why choose Qserve?
Qserve has an international and dynamic work environment in which you can learn, develop and operate in the innovative, fast-moving medical device sector. We offer flexibility and diversity in terms of clients, devices, technology, roles (author, reviewer, expert, trainer, auditor, etc.) and projects. Work together, learn from and be part of a strong international team with technical, regulatory, quality and clinical competences (altogether over 500 years of experience). And last but not least we offer a balanced set of core benefits that we believe are important to all employees.
“Global reach, practical approach, experienced team”
Getting excited about a career as a consultant or clinical operations professional in the dynamic and innovating world of medical devices? Then please submit your resume and letter of motivation to firstname.lastname@example.org
or use our application form on our website: https://qservegroup.com/en/careers.
For more information about our company, you can always visit our website (www.qservegroup.com) or contact our HR department at +31 20 78 82 630.
The position is mainly home-based; this position requires limited or no national and international travel.