|Job Function||NIEUW: Clinical Study Researcher|
|Short Description||For our client we are looking for a Clinical Study Researcher. We can offer a 1 year contract, and a PhD is required for this position.|
|Company Profile||A large global company in nutrition and health.|
|Function Profile||The Clinical Study Researcher is a member of the Center of Excellence Clinical Research and provides scientific, clinical expertise in our research projects. In this role you will be responsible for study design, writing of the protocol, analysis, interpretation and reporting of the study in accordance with the clinical study plan, applicable legislation and Standard Operating Procedures. The Clinical Study Researcher has strong scientific skills, is able to translate business need and literature data into one or more clinical studies, is experienced in the writing of scientific publications and has effective networking skills. In addition, you will also be responsible for the scientific input on study methodology of clinical studies related to gut health within the Clinical Studies program in general e.g. by developing and reviewing study protocols, reviewing study documents, aligning with stakeholders, and collaborating with clinical partners and third parties.|
Other key responsibilities
Translate business needs and literature data into a clinical study
Provide scientific support during all phases of the clinical study
Assess scientific feasibility of the study protocol and be involved in the investigator selection process
Write the scientific part of Statistical Analysis Plan
Write the clinical report upon completion or termination of studies
Prepare manuscripts for technical journals and make presentations at scientific meetings.
Safeguard the quality of your studies
Liaise with doctors, scientists and health professionals.
Build internal and external networks of Key Opinion Leaders/investigators/experts and other stakeholders
Supervise third parties if activities are outsourced
|Function Criteria||You will possess the passion and readiness to commit to making health differences, bringing scientific evidence to products and services. As a minimum, you hold a PhD in life science or related scientific discipline and have profound experience in (international) clinical research in an academic setting or the (bio-) pharmaceutical industry. You have thorough scientific knowledge in study methodology and expertise concerning clinical research and literature data, preferably related to gut health.|
In addition, the candidates knowledge, skills and abilities:
Have knowledge of ICH-GCP guidelines, legislation, SOPs and ISO9001:2008(15) standards and high respect to quality and ethics
Scientific expertise in the field of gut health (or related area) is an advantage and/or you are willing and able to become familiar in this field.
Curiosity to connect science and methodologies into opportunities within one study and/or across different studies
Passion to connect people and mobilize networks to work together to achieve high quality results
Ability to innovate and solve challenges with a unique approach
Excellent command of spoken and written English for writing papers, reports and delivering presentations
Ability to focus on the long-term vision and be adaptable to the changing needs of the business.
Ability to think logically and analytically
Good time management and organizational skills
Ability to interact and communicate effectively with a wide range of people