To support our team, we are looking for a Clinical Trial Manager (m/w/*) as a fulltime employee (40h/week), home office based located in the USA. Reporting line to the Vice President of Clinical Affairs.
Your responsibilities:
- Successfully manage any assigned studies ensuring completion of the deliverables.
- Create, review, and/or oversee study documentation such as protocols, case report forms, monitoring plans, data management plans, statistical analysis plans, etc.
- Lead the development of study tools and training materials.
- Organize, oversee, or perform study operational elements such as site feasibility, qualification, selection, initiation, monitoring, for-cause site visits, and close out.
- Oversee study laboratory investigational product management, sample management and sample testing.
- Participate in oversight of any CROs or vendors engaged by Mainz Biomed.
- Assist with site engagement and support.
- Lead team study meetings.
- Communicate any challenges to study timelines and deliverables and help with creative solutions.
- Create and/or edit department SOPs and other procedures.
- Mentor and train junior department members.
- Up to 50% travel may be required.
Your profile:
- Bachelor’s degree or combined equivalent education and experience in a science or health-re-lated field.
- At least 5 years clinical research experience on IVD clinical studies (7 years for Sr. Clinical Trial Manager).
- Independent field monitoring experience.
- Experience with EDC and eTMF systems.
- Extensive knowledge of US 21 CFR, GCP and ICH Regulations.
- Clinical research certification (e.g. CCRA or CCRP) desired.
- Study experience in a leadership role desired.
- Excellent organizational and time management skills.
- Excellent verbal and written communication skills.
- Ability to work with and lead a multifunctional team.
- Skills in negotiation, building positive interpersonal relationships, critical thinking, flexible thinking, and making decisions.
- Advanced knowledge of MS Office products.
We offer:
- A wide range of activities
- Attractive compensation including stock options
- Flexible working hours and work location
- Flat hierarchical structures
- The chance to contribute to an innovative and highly motivated team
Are you interested? Then please send your application documents, your salary requirements, and your earliest possible starting date by e-mail to jobs@mainzbiomed.com. Your contact person, Jane Edwards will be happy to answer your questions in advance via this e-mail address.
