Clinical Project Manager Medical Devices (m/f)

REFERENZNUMMER:

237052/11

IHRE AUFGABEN:

-Responsible for the day-to-day management of investigational (prä CE- Studies) clinical studies
-Responsible for the preparation, including coordining translations, of study protocols, informed consent forms, case report forms, and other study related documentation
-Works closely with data management group from study design through to reporting of results
-Create and maintain study timelines
-Manage study budget
-Organizes and leads internal meetings with associated communications
-Act as principle liaison between investigators, contract research organizations, central laboratories, and other study vendors
-Negotiates budget and contracts with investigators, central laboratories, and other study vendors
-Trains investigators, research coordinators, contract research organizations, central laboratories, and other study vendors on all study procedures
-Provides input on the reportability of adverse events and other clinical study issues to regulatory agencies
-Assists in the preparation of regulatory documents and submissions as needed
-Contributes to scientific publications in international peer-reviewed journals and other publications as appropriate
-Assists in improving department SOPs and policies
-Identify and implement process improvements
-Collaboration with internal customers including Research & Development, Quality Assurance, Regulatory and Product Teams
-Routine contact with clinical study surgeons and their staff
-Up to 20% travel, both domestically and internationally, required

IHRE QUALIFIKATIONEN:

-Bachelor's Degree required
-Experience in medical device industry, clinical setting, or research field required
-Working knowledge of local and international regulations for conducting human clinical studies
-Ability to handle complex projects with great attention to detail
-Demonstrates problem solving and judgment skills
-Excellent understanding of Good Clinical Practices and current regulations regarding clinical studies
-Ability to participate in cross-functional teams, team player and contributor
-Demonstrates ability to perform assignments independently, and with high level of initiative in all aspects of work
-Excellent interpersonal and communication skills, both written and verbal. Strong verbal and oral presentation skills
-Professional, ethical and dedicated
-Experience working with Microsoft Office (Word, Excel, Outlook, Powerpoint)

WEITERE QUALIFIKATIONEN:

Clinical project manager, Clinical trial manager