The scope of responsibilities will include:
- Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
- Site management, general administration of clinical research studies in France
- Contact for clinical investigators, vendors and support services in regard to study progress
- Monitoring trial progress and ensuring that the project timelines are met
- Facilitation of site budgets and contract negotiations
- Effective and open communication within the project team
- Delivering onsite training of investigators and staff
- Preparation and delivering of presentations at Investigator’s Meetings
- Preparation for and attendance at company’s audits; resolution of audit findings
- Support to Regulatory Affairs in procurement of site regulatory documents
- Maintenance of appropriate documentation regarding clinical site management
- Participation in feasibility research
- Participation in query resolution
- Maintenance of study-specific automated tracking systems
- University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience
- Significant hands-on industry experience at a similar position, with full scope of monitoring responsibilities within Phase II/III Clinical Trials
- Independent monitoring experience in France
- Experience in regulatory submissions, contract negotiations, site management and feasibility assessment
- Experience with Oncohematology indications
- Fluent French and English, spoken and written
- Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
- Attention to detail, organizational and time-management skills
- Demonstrated ability to multitask and work proactively in a fast-paced environment
- Good problem solving abilities, flexibility
- Valid driver’s license and ability to travel
- Demonstrated computer skills (MS Office applications)
- We are recognized by a unique combination of team collaboration and independent work, global dimensions and individual approach.
- We provide a stable and secure workplace, while giving opportunities for innovative ways of doing things.
- We provide high-quality employment, competitive salary, excellent working conditions and a personable supportive environment.
- It is a great chance to join the company that really cares for its people, and invests in their professional development and success.