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Clinical Trial manager

  Dublin,  Ireland |  Full time

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Posting Date :  2021-05-24

Job Identification :  10821

Department  :  Research & Development

The Clinical Trial Manager will direct, plan and manage, in collaboration with his/her team and peers, all clinical trials and Environmental Risk Assessment (ERA) studies necessary for Bimeda’s worldwide New Product Development and Registration program.

Key Reponsibilities:

  • Lead and coordinate the R&D Global Clinical Trial Program and activities
  • Provide guidance and direction to all stakeholders in relation to Clinical Trials and ERA studies
  • Be accountable for the design, planning and reporting of specific multicenter clinical trials and ERA studies
  • Coordinate with other Bimeda regions with respect to Clinical Trial activities; with an emphasis on leveraging knowledge and experience from other Bimeda sites
  • Duties in Innovation CI and risk taking. Provide leadership and support on an inter-departmental basis in relation to the New Product Selection process
  • Facilitate, plan, direct and provide technical support to the CRO`s in the conduct of all studies
  • Ensure SOPs and documentation are consistent with the company operations and in compliance with the relevant statutory requirements in the countries under scope
  • Prepare Expert Reports where applicable for Part III & IV submissions
  • Engage with statisticians and other specialists to ensure valid analysis of all trial outcomes
  • Communicate all trial status to stakeholders/senior management on a regular basis escalating issues as appropriate
  • Act in front of the regulatory authorities in the area as responsible Clinical Trial Manager
  • Direct, supervise and evaluate your work team and demonstrate strong adherence to requirements of working in a multi-cultural environment. A strong understanding of corporate culture dynamics is required
  • Administer and manage the resources assigned to the area (financial, human, material). Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions
  • Act as a team leader supporting the Clinical Trial team in the accomplishment of their goals and in their professional development; take charge of the teams’ performance reviews and goal setting; actively participate in recruitment processes and candidate selection 

 

Requirements:

 

  • At least 5 years of industry experience in the area of Clinical Trial Design and Management with a proven track record in successful interactions with animal health agencies
  • Salary circa €90,000 DOE

 

Essential:

  • Knowledge of Clinical Trial Design including Bioequivalence, Residue & Efficacy Studies as well as ERA trial work
  • Thorough understanding of Regulatory Agency requirements (FDA, EU etc.) in relation to Animal Test Certificates and all regulations
  • Previous experience managing a team

 

Desirable:

  • Veterinary or Life Science Degree. Post Graduate degree would be desirable

 

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.


global

OPERATES
IN OVER
75
countries

people

800+
EMPLOYEES

lab

6
R&D and
REGULATORY
LABS

factory

11
MANUFACTURING
facilities in
8 COUNTRIES

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