The AKKA Technologies Group (12'000 employees, 1.2b EUR turnover) is a leading technical consultancy group, developing its AKKA LifeSciences brand through Europe.
On behalf of one of our best clients, a leading medical device manufacturer we are currently seeking a Clinical Project Lead to join ASAP their international team in a permanent basis.
You will be leading and coordinating the clinical study development, initiation, monitoring and management, performing following task:
Managing the regulatory approval of monitored studies, site start-up, quality maintenance, report generation and presentation development
Conduct site visits including site assessment, interim monitoring for appropriate patient enrolment and documentation compliance and close out or termination visits
Lead presentation of study design, clinical program and contractual agreements to potential investigators
Conduct training of research coordinators and surgeon office staff on data collection methods
Supporting submission of protocols to ethics committees and competent authorities for review and approval
Collaborate with biostatisticians to design study databases, evaluate data and assist in producing surgeon requested analysis and presentations on clinical results
Consult with marketing and engineering staff concerning risk analysis, clinical assessments, clinical projects status, and results of the clinical trials
Building strong relationships with surgeons, radiologists and research staff involved in clinical research
BSc or MSc degree (or equivalent education in technical area - biomedical sciences or engineering)
Previous experience in working in clinical researches of medical devices with direct responsibility for protocol submissions, development and content.
Fluent in English (German, French or other major language is an asset)
Proficient in Microsoft Office applications and general computer software skills
If this sound like your next challenge please send me your updated CV to (see below) or call me for more details.This is a Permanent position.