clinical affairs associate/lead in Eysin

For our client,a growing company in the IVD field, we are looking for a: 

Clinical affairs associate/ leadLocation:Canton of Vaud

Contract: Permanent

The Clinical Affairs Associate is responsible to conceptualize, plan, design, execute and monitor clinical field trials required as part of the licensing and registration of the medical device instrument and consumable product in development by the company. 

Your main responsibilities: 

• Be in charge of planning and management of the clinical field trials including related management of potential contracted organizations conducting field trials in foreign countries.

• Negotiate and administer all activities with potential field trial sites and / or Contract Research Organizations concerning contracts and activities in collaboration with the Finance & Administration department

• Work with the Contract Research Organizations (CROs), guide and assist the development of EDC database

• Coordinate clinical field trial development activities and strategies

• Coordinate instrument placement and associated activities involved in instrument management during the field trial process

• Lead in the development of clinical trial designs with internal resources and or Clinical Research Organizations

• Perform site initiations, monitoring visits, close out visits as required

• Work with physicians on an individual and group level to develop and execute clinical field trails that meet company Marketing, Regulatory and R&D requirements

• Provide visibility to Sales organization on status of clinical field trial sites and principal investigators

• Responsible for completion, compliance and assessment of safety / efficacy reports as required by the Food and Drug Administration and international regulatory bodies, clinical development plans, and research strategies

• Manage, train, and monitor Clinical Research Associates in the production and administration of clinical study protocols

 

Your profile: 

• A relevant degree or professional qualification, Clinical Affairs Professional Society certification or advanced degree in clinical affairs desirable

• Significant knowledge of clinical affairs as applied to in vitro diagnostic medical devices and instrumentation and an understanding of the operation of a medical device manufacturing establishment

• Ability to analyze information in a structured manner and to be able to prepare coherent technical reports

• Understanding of budgetary process and requirements for managing a department

• Working knowledge of GMP, ISO 13485 and IVDD requirements

• Deep knowledge of international regulatory agencies and submission processes is required

• Team player and effective communication with a wide range of international customers, clinical trial sites and authorities at all organizational levels

• Effective time management and prioritization skills, ability to self-motivate and great attention to detail with a thorough and methodical approach

• Ability to work under pressure, meet deadlines and respond flexibly

• Ideally fluent in multiple languages (English mandatory)

• Ability to travel (approximately 25%) will be an essential part of this position