Clinical Research Manager (US)

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

Originally posted on Himalayas