ROLE AND RESPONSIBILITIES
The CTM will be responsible for implementing and overseeing of clinical trials in compliance with all applicable
county, state, and federal regulations and for ensuring the quality of the trials.
Main responsibilities are:
· Planning and executing clinical trials with/out CRO, from protocol concept through the clinical study
until to its completion and deliverables, all in compliance with SOPs, ISO, ICH-cGCP’s guidelines and any
other relevant local/international guidelines.
· Creating and implementing study-specific clinical monitoring tools and documents.
· Ensuring all medical& clinical trials records and other care-related documentation are up-to-date.
· Creating and overseeing the trial budget.
· Identifying, enlisting, and choosing sites, and coordinating site management activities.
· Coordinating and supervising clinical monitoring teams.
· Arranging and overseeing site visits.
· Leading the interactions with the study CROs and other 3rd party vendors.
· Educating and support physicians and hospital relevant personnel on the correct use of products.
· Providing CRAa with project-specific training.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
· Proven experience as a senior CRA/CTM in the pharmaceutical or medical device sectors
· Experience in managing clinical trials according to the FDA/EMEA/Israeli MoH and ICH-cGCP
guidelines/regulations
· Experience working with several CROs / worldwide multi sites – advantage
· Experience in managing interactions with CROs, competent authorities (such as FDA, EMEA, Israeli
MOH) and principal investigators
· Solid understanding of budgeting, resourcing and performance evaluation procedures
· Excellent knowledge of standards (e.g., ISO) and other regulations in the medical device field
· Proficient in MS Office and specialized computer systems (e.g., patient management softwares)
· BSc/BA in clinical administration, medical science, biochemistry, microbiology or relevant field; MSc
level will be appreciated
PREFERRED SKILLS
· Excellent communication (verbal and written), influencer and persuasive
· Exceptional organizational, analytical and leadership skills
· Ability to work independently and prioritize duties.
· Aptitude in resolving issues and conflicts
· Prior experience in orthopedic medical solutions – an advantage
ADDITIONAL NOTES
English at mother tongue level – preferred
Other languages – an advantage