Senior Clinical Project Manager (m/f/d)
BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.
The Medical Affairs Group is responsible for the design, conduction, and evaluation of international first-in-man, regulatory submission, and post-marketing trials.
Conduct and oversight of international clinical studies within agreed timelines and budget
Define and author all essential clinical study documentation (e.g. Clinical Study Protocol or Clinical Investigational Report) as required by MEDDEV 2.7.1, MDR 2017/745, ICH-GCP, ISO 14155, FDA, PMDA, and local legal requirements
Coordinate and support internal and external interfaces within clinical studies and build up strong relationships with key opinion leaders
Execute or coordinate the regulatory submissions to Ethics Committees and Competent Authorities as applicable
Assure the handling and reporting of safety information in clinical studies according to regulatory requirements as well as readiness for internal and external audits
Be on top of the main literature and competitive environment in the field
Oversee the monitoring activities for assigned clinical studies (Site Evaluation, Site Initiations, Site Monitoring, Site Close Out Visits) in collaboration with the monitoring representatives and/or external providers
Select and manage external vendors within assigned clinical investigations
Collaborate closely with the Clinical Data Management/Statistician for assigned clinical studies
Plan and control the budget for assigned clinical studies
Prepare abstracts and presentations for congresses
Support and review draft publications for peer-reviewed journals
University or bachelor`s degree in science; medical education is an advantage
Minimum of 3 years in clinical project management role in Clinical Research Department in Medical Devices / Phamraceutical companies / CRO or a minimum of 5 years as a CRA in EU
Knowledge of Good Clinical Practice (GCP) and ISO 14155, experience with Class II & III medical devices preferred
Literate in Microsoft Office applications
Fluency in English and basic German; any additional language is an advantage
Team- and customer-oriented, analytical and detail-oriented, flexible and communicative personality with excellent soft skills
Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.
Location: Bülach | Working hours: Vollzeit | Type of contract: Unbefristet
Apply now under: www.biotronik.com/careers
Job ID: 47594
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.