Clinical Project Manager Medical Devices (m/f)

Central Switzerland/Swiss Plateau region  ‐ Onsite
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Keywords

Description


We are looking for a
Clinical Project Manager Medical Devices (m/f)

Reference: -en
Start: asap
Duration: 12 MM++
Place: in Central Switzerland/Swiss Plateau region
Branch: Herstellung von orthopädischen und prothetischen Erzeugnissen

Your tasks:
  • 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


Your qualifications
  • 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)



Skills:
- Clinical project manager
- Clinical trial manager
Start date
ASAP
Duration
12 MM++
(extension possible)
From
Hays AG
Published at
27.03.2014
Contact person:
Kerstin Sieber
Project ID:
685873
Contract type
Freelance
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