This is a full-time and temporary position, starting from August 2024 to March 2024 (8 months).

YOUR MISSION

The Clinical Affairs Lead 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 AliveDx.

More precisely, your main responsibilities will include:

• Be in charge of planning and management of assigned AliveDx clinical field trials related to MosaiQ 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
• Collaborate with external companies and the FM society responsible for building maintenance.
• Welcome and monitor subcontractors according to defined specifications.
• Maintain existing building infrastructure actively participate in modernization projects of installations.
• Contribute to creating or modifying preventive plans for building equipment.
• Maintain updated plans, manage orders and invoices.

YOUR COMPETENCIES

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

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.

Interested? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.