Edwards Lifesciences Clinical Trial Admin TMTT in Czech Republic
Main Activities / Summary:
Under the general direction of the Director, Clinical Affairs, or Manager coordinates all Clinical Affairs internal functions such as initial preparation of study site materials, maintenance of department invoices, planning and preparation of department and investigator meetings.
Works closely with the Clinical Project Manager and Monitors to provide internal support to keep projects within established timeframes by completing mailings, copying functions and interfacing with Regulatory, Quality, Legal and other support services
Coordinate and maintain clinical research administrative requirements
Tasks assigned to the position:
Processing and printing study case report forms for submissions and preparation of study site folders and patient study binder. Any other work related to study logistics – shipments, burning CD and labelling etc
Printing, administration and archiving contracts (consultancy agreements, external training provider etc.)
Processing and administration of department correspondence
Support Clinical Director / Manager, Clinical Project Manager and Monitor personnel where appropriate, including travel arrangements.
Preparation of department related presentations where appropriate
Preparation and maintaining of department Orgchart
Assist in planning and preparation of department meetings, congress participation, and investigator meetings.
Central archiving of study documents during and after a study closure
Maintain electronic file system for all CA files
Maintain EW and CA templates electronically
Organize and order working material incl. preparation for new CA team members.
ordering of IT equipment like laptop, monitor, keyboard, telephone, mobile, usernames/passwords
preparation of working place – basic material (paper, pen, puncher etc.)
Support safety reporting and communicate to respective clinical project manager / safety officer upon awareness of SAEs
Requirements / Skills
Completed educational program or training in commercial industry, preferably in medical devices or Pharmaceuticals. Computer skills in word processing, presentation and calculation software.
High school degree and experience in business administration required.
Professional experience in business administration
Minimum of one year in administrative role in Clinical Research Department in Medical Devices / Pharmaceutical companies, Clinical Research Organizations or 3-5 year experience as assistant in administrative roles.
Experience / special knowledge:
Good oral and written communication skills
Excellent organizational skills
Ability/experience in working in functional teams with several persons and various cultures
Able to manage multiple projects
Demonstrate time management and prioritization skills
Ability to respect and eventually implement procedures
Good computer skills in word processing, presentation and calculation software
Medical device experience and / or clinical research experience are of advantage
Must be self-motivated, goal-oriented with high level of energy
Team player with excellent communication skills
Ability to work in a multicultural environment
Ability to work well with other functional groups (internal & external)
Very good English are mandatory including medical terms. Either very good German or French language skills in writing and verbal communication are of big advantage, all other languages are an asset.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Clinical Trial Admin TMTT Location: Europe, Middle East, Africa, Canada (EMEAC)-Czech Republic Job Number: 011097