Job Detail

oining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

The principal purpose of this job function is to provide support for Clinical Affairs (CA) project documentation and operational support. In addition, to provide administrative support to the CA team in daily business activities.

This position is based at the Intuitive Surgical EMEIA Head Office in Switzerland.

Roles and Responsibilities:

• Take part in preparation and tracking of research budgets, payments and documentation and provision of updates to the finance department


• Establishes, organizes and maintains study files (paper and electronic) including but not limited to, regulatory binders content, study specific source documentation, contracts, payments etc. and other materials.


• Support preparation of study-related documentation such as protocol worksheet, procedure manuals, and progress reports


• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts


• Support project managers on adverse event reporting and other informational materials to be used in subject recruitment


• Check CA activities comply with IS quality system and raise opportunities for improvements in process


• Participate in quality assurance audits conducted by study sponsors and regulatory agencies


• Responsible for drafting and tracking of CA contracts and NDAs


• Maintain documentation of CA training outside ISU


• Manage CA meeting arrangement support e.g. internal meetings and advisory boards; including all logistic arrangements and consolidation of materials.


• Support literature requests for all relevant departments


• Attend conferences and seminars to maintain current knowledge of CA regulations, laws and best practice


• Responsible for maintenance of EU CA project tracking, intranet page and CA newsletter


• Administrative support for the CA team

Required Knowledge, Skills, and Experience:
 

• At least 1 year experience within a Clinical Affairs role


• Previous similar administrative experience 2-3 years minimum


• Minimal travel - arrangement of meetings, travel accommodation, facilities, materials


• Excellent communication, written and oral interpersonal skills with high attention to detail


• Demonstrated superior ability to organize, prioritize and manage multiple tasks simultaneously


• Flexible and reliable


• MS Office proficient, excel, word, outlook, power point


• Fluent at least in English and French


• CTMS

Preferred knowledge, skills, and Experience:

• BS in Life Sciences or documentation management


• Fluent in other EU languages

Shift : Shift 1 - Day

Travel : No

Travel: No

Shift: Shift 1 - Day

Job level: