Edwards Lifesciences Clinical Project Manager TMTT in Czech Republic
Main Activities / Summary:
Act as a Clinical Project leader, being the overall responsible for an assigned clinical investigation. Plan, set-up, execute, co‑ordinate and be responsible for assigned clinical investigations according to accepted standards (i.e. ISO 14155, ICH-GCP), international registration requirements, as applicable, and according to Edwards Lifesciences procedures (SOPs).
Prepare, initiate, conduct and manage assigned clinical investigation within defined budget and timelines.
Tasks assigned to the position:
Define and author clinical investigation documents (e.g. CIP, CRF, informed consent, patient information) as required by ISO 14155, ICH-GCP and applicable standards. Ensure proper review and quality control of clinical investigation documents.
Define, author and be responsible for submission of clinical investigations to the required ethic committee/review boards and competent authorities, as applicable. Coordinate with the department of regulatory affairs especially for investigations with products which do not have market approval.
Manage external providers within assigned clinical investigations; drive the selection process.
Ensure study specific training for participating parties (e.g. CRAs, investigators, site personnel) as far as necessary to ensure adequate quality of the assigned clinical investigations.
Maintain regular visit and/or telephone contacts with study investigators and other study specific interfaces.
Supervise the monitoring for assigned clinical studies according to ISO 14155 / CFR FDA and ICH-GCP standards in collaboration with the monitoring representatives and/or external providers. Perform monitoring or co-monitoring visits as applicable.
Supervise the completion, source verification, collection and review of data in clinical investigations.
Hold close contact with the data manager and/or statistician and support him/her in the set-up and maintenance of the study data base, coordinate and complete study specific requirements.
Assure proper handling and reporting of all safety and clinical events according to regulatory and study specific requirements for all devices being tested in clinical investigations. Hold close contact with the safety reporting team.
Plan and control the budget for assigned clinical investigation.
Report/communicate relevant details and milestones concerning the clinical studies to the Director, Clinical Affairs or upper Management. Enable adequate management actions where necessary.
Organize the archiving of clinical investigation documents within his/her responsibilities.
Be prepared for internal or external ISO 14155/ CRF FDA/ICH-GCP audits within assigned clinical investigations.
Review regularly relevant literature and other sources for information supporting his/her ongoing and future projects and to support information management systems, as available.
Be up‑to‑date with all current trends in the Clinical Affairs field by regularly screening the relevant literature, guidance and regulatory documents, attending congresses or scientific meetings, and attend trainings, as applicable.
Support the Director CA in representing the Clinical Affairs department within the company and outside.
Requirements / Skills
Thorough, conscientious and results oriented working style. Computer skills in word processing, presentation and calculation software. Strong communication and organization skills, team spirit, good written and spoken German or French and English language skills.
University degree or equivalent in scientific or medical field required with at least 2 year experience in clinical project management.
Alternatively good medical background (e.g. nurse, cath-lab technician) with at least three years of CRA experience; or comparable experience in clinical research.
Minimum of one two years in clinical project management role in Clinical Research Department in Medical Devices / Pharmaceutical companies / CRO.
Basic knowledge of European and international regulations of Good Clinical Practice (GCP) and ISO 14155, experience with Class II & III medical devices preferred, documented basic continuing education in clinical research or experience in clinical research
Experience / special knowledge:
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
Clinical research and project management experience
Familiarity in hospital environment
Experience in interaction with ethic committees and competent authorities required.
Experience in authoring of clinical investigation plans and other study documents required.
Experience in authoring of standard procedures and investigator brochures is an asset.
Knowledge of clinical investigations under an investigational device exemption (or IND) is an asset
Detail-oriented and very precise
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, all other languages are of advantage
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 Project Manager TMTT Location: Europe, Middle East, Africa, Canada (EMEAC)-Czech Republic Job Number: 011095