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The Project Manager Veterinary Clinical Studies acts as the primary interface between the project team and the client. The Project Manager is responsible for the overall conduct of projects under their management, including resource management, budget, and timelines.
The successful candidate will possess strong knowledge of VICH GCP regulations and will have experience managing multi-site, pivotal clinical studies. As a member of the Clinical Development Team the position holder 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).
This position will have strong communication and resource-management skills in a client-driven environment.
- Manage projects involving the development of veterinary vaccines or pharmaceuticals, including setting up projects within the knoell ERP system, kERMIT.
- Compile proposals for projects and negotiate contracts with both clients and third parties.
- Monitor and track project time and pass through costs budgets and have responsibility to approve third party invoices related to the project.
- Ensure the direction of members of the team selected for roles in the project by organizing and leading project meetings.
- Attend and organize client and third party visits and meetings.
- Participate in VICH Good Clinical Practice (VICH GCP) veterinary clinical studies in the role of Monitor.
- Compile and peer-review Standard Operating Procedures, clinical study Protocols and Study Reports, data collection sheets, general forms, and other associated documents using knoell Animal Health templates, 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 organisations, etc.) to recruit, qualify and train study participants, review the performance of the study and verify the data collected.
- Compile Monitor reports of visits to report on the progress of the study and obtain corrective actions as necessary.
- Overview of regulatory studies (performed in compliance with Good Laboratory Practice (GLP) or GCP or other applicable standards) conducted by third parties related to the development of veterinary vaccines or pharmaceuticals, in the role of Sponsor Representative.
- Entry of study data and/or Company administrative data into spreadsheets and databases. Verification of this data when applicable by using established quality control techniques. Analysis of data using simple functions, including statistical features, to prepare tables, graphs, charts and reports.
- 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.
- Bachelor’s degree (or equivalent) required, preferably in animal science, biology, or related life science/medical fields.
- Minimum of 5 years of clinical study experience in the animal health field.
- Experience with GCP and/or GLP studies.
- Experience working in private veterinary practice is a plus.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong verbal and written communications 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.
At knoell Animal Health, LLC you will be working in a professional, fast-growing, international organization. We offer a competitive compensation package teamed with comprehensive benefits.