Clinical Research Manager

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world's leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.
Your Responsibilities
Cultivate a portfolio of clinical research projects and a network of clinical research sites and investigators to support Medartis business and regulatory requirements
Create new and maintain existing customer contacts to include visits, trainings and advice acting as the point of contact between internal and external partners
Create new and maintain existing processes within the Medartis quality system ensuring that all processes comply with internal and external regulatory and legal requirements
Select and support preclinical and clinical studies (including patient registries, retro- and prospective studies, case study reviews, pre-clinical modeling, possible PMA studies, etc.) by
proactive engagement of study institutions and clinical researchers to participate in studies
directing communication with the study director from the conception phase until publication of the final report,
providing support with
writing of study protocols contractual questions and follow up as required
regulatory requirements (lRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting)
statistical analysis and scientific writing (written reviews for publication/ presentations)
implementation of digital tools such as databases, EDC solutions, registries, (e)CRFs, etc. and training of study staff (nurses, PIs, etc.) on said tools
supplying study hardware
coordination with CROs
preparation and maintenance of TMF and ISF
support of study site(s) and study nurse(s); e.g., with questions relating to data entry
visits and/or on-site monitoring of study sites
timely communication with all relevant regulatory bodies/lRBs
study follow up and data collection with
Responsible for the complete development of study protocols that meet FDA clearance standards, maintain the continuum of support documentation to further validate the proper ‘Indications for Use' via education and training on the future and existing Medartis product offerings
Your Qualifications
Conscientious, careful, punctual, and reliable work approach
Fast comprehension and ability to quickly familiarize oneself with new subject areas
Can work independently and motivated in a small group of specialized experts
Willingness to take initiative and act autonomously
Demonstrates assertiveness and patience in daily work
Relationship development in settings of the field, labs, conferences, or dinner meetings
Conscientious, precise communication
Degree in a STEM field at a university level or equivalent professional experience/training; PhD and GCP certificate desirable
Familiar with logistical and regulatory issues in the field of clinical studies
Familiarity with the field of orthopedic surgery or orthopedic medical device design preferred
Knowledge of statistics is advantageous
Proficient in office applications
Familiarity with EDC software solutions is advantageous
Scientific, structured, rigorous, and strategic work approach
Willingness to travel (up to 20%)
Fluent (spoken and written) in English, other languages are advantageous
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.
We look forward to receiving your complete online application.
Medartis
Human Resources
T +1 610 961 6101
www.medartis.com

Work arrangement
Yes