Clinical Trial Monitor, Animal Health

At knoell Animal Health, you are part of an international team of approximately 40 Animal Health experts including specialists in pharmaceuticals, biologics, feed additives, toxicology, safety, chemistry, and clinical studies. We support manufacturers of animal health products with our extensive expertise at every point of the product life cycle. Our animal health experts support our clients in gaining access to global key markets including Europe, North & South America, and Asia.

The Clinical Trial Monitor in Veterinary Clinical Development acts as the primary interface between the project team and the Investigator.  The Monitor will be responsible for the initiation, routine monitoring, and close out of study sites as part of the larger study team.

This role requires strong knowledge of VICH GCP regulations and experience managing multi-site, pivotal clinical studies in the field. As a member of the Clinical Development Team, this role is involved in the planning, conduct, and reporting of Veterinary Clinical Studies conducted in compliance with VICH Topic GL9 (GCP), Guideline on Good Clinical Practice: (CVMP/VICH/595/98 – Final, or CVM GFI #85 (VICH GL9) Good Clinical Practice).

• Participate in VICH Good Clinical Practice (VICH GCP) veterinary clinical studies in the role of Monitor.
• Responsible for or contribute to the creation, development, and execution of documents for study build that may include, electronic data capture (EDC) or paper studies.
• Compile and peer-review Standard Operating Procedures, clinical study Protocols and Final Study Reports, Data Collection Forms, and other associated controlled documents within the knoell Animal Health Quality Management System, according to appropriate guidelines and in accordance with training and competency. 
• Conduct Monitor visits at study sites (including commercial farms, veterinary practices, kennels, stables, laboratories, contract research organizations, etc.) to recruit, qualify and train study participants, review the performance of the study and verify the data collected.
• Compile Monitor visit reports, identify, and track adverse events (AEs), report on the progress of the study and obtain corrective actions as necessary.
• Enter study data and/or company administrative data into spreadsheets and databases. Verify data when applicable by using established quality control techniques. Analyse data using simple functions, including statistical features, to prepare tables, graphs, charts, and reports using Microsoft Office.
• Adhere to the following in all appropriate aspects of the position:
  • Maintain documentation, records, data in general adherence to applicable standards, internal quality systems and policies of knoell Animal Health. 
  • Communicate with clients and other external bodies in line with company policy. 
  • Conduct other work suitable to abilities, training, experience and position, as requested. This may include administrative tasks and assistance to other Company personnel. 

Essential Requirements

• Bachelor’s degree or equivalent experience required, preferably in animal science, biology, veterinary, or related life science or medical fields
• Previous experience with VICH GCP studies is essential
• Ability to travel to study sites or client meetings up to 35% of time; travel may be intermittent but can usually be planned.

Additional Preferences

• Ability to multitask and prioritize to meet deadlines in timely manner.
• Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization and the client’s organization if applicable.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to work independently with limited oversight.
• Ability to identify and solve problems in a strategic manner.
• Ability to be proactive and anticipate the dynamic needs of clinical studies.

• Work in a dynamic family-owned business environment with an international team in which new ideas, creative approaches, and collaboration are valued.
• You will have the opportunity to work with market leaders in our industry.
• Development is core, and at knoell we offer various opportunities to support your personal, leadership and technical development, including English language courses to help you effectively communicate in our business language.
• knoell offers a flexible working policy and is a remote-first company, where you have the flexibility to work from home, at our headquarters in Mannheim or at one of our local offices based in your location. 
• Part-time work options are generally supported on request subject to meeting business requirements.
•  It is important to us that you have both a career and personal life – we celebrate the work-life balance of our colleagues.
• At knoell we have a global employee referral program as part of the recruitment process where you can actively participate and get rewarded for referring talent to knoell.

We look forward to receiving your application!