Clinical Trial Manager

JOB DESCRIPTION

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.

JOB DESCRIPTION PDF

CLICK HERE TO VIEW/DOWNLOAD JOB DESCRIPTION PDF FILE: Clinical Trial Manager_2022-09-19 vfinal_EN

POSTED DATE

October 12, 2022

CLOSING DATE

January 1, 2023

STARTING DATE

February 1, 2023

LOCATION

Mainz, Germany

REFERENCE NUMBER/ID

MB025

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