Clinical Research Manager

Medartis Inc. - United States; Warszawa; On-site; PLN 150,000 - 210,000; Full time

Job summary

Medartis seeks a driven clinical research professional to lead study programs, ensure regulatory compliance, and coordinate across global study sites.

You will manage studies from conception to publication, engage investigators, and implement digital tools while supporting QA and regulatory requirements. Travel up to 20% is expected, with fluent English communication across teams.

Qualifications

• Degree in a STEM field at university level or equivalent experience.
• PhD and GCP certificate desirable.

Responsibilities

• Cultivate a portfolio of clinical research projects and a network of sites and investigators.
• Create and maintain customer contacts, visits, trainings, and advisory roles.
• Maintain Medartis quality system processes ensuring regulatory compliance.
• Select and support preclinical and clinical studies (registries, retro-/prospective studies, PMA, etc.).
• Engage study institutions and researchers to participate in studies.
• Direct communication with study director from conception to final report publication.
• Provide support with study protocols and follow-up contractual questions.
• Address regulatory requirements (IRB, ethics committees, ICH-GCP, ISO 14155, SAE reporting).
• Perform statistical analysis and scientific writing for publications/presentations.
• Implement digital tools (databases, EDC, registries, eCRFs) and train study staff.
• Supply study hardware and coordinate with CROs.
• Prepare and maintain TMF and ISF.
• Support study sites and nurses for data entry questions.
• Visit and/or monitor study sites on-site.
• Maintain timely communication with regulatory bodies/IRBs.
• Oversee study follow-up and data collection.
• Develop protocols meeting FDA clearance standards and support documentation.

Skills

Conscientiousness

Fast learning

Independent

Initiative

Assertiveness

Relationship building

Clear communication

Willingness to travel

Fluent English

Education

STEM degree

PhD desirable

Tools

EDC software

Job description

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.

Medartis

Human Resources

T [phone]

www.medartis.com