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Study Monitor

51138
Study Monitor
sydney
New South Wales
Asia/Pacific
Australia
Company profile:
Elanco is a global, innovation-driven animal health company that develops and markets products to improve animal health and production in more than 75 countries. Elanco’s research and development focuses on products in veterinary healthcare and food animal productivity

 Responsible for monitoring GCP studies to ensure compliance with VICH (GL9) Guidelines

Conduct QC reviews of GLP and non-GxP studies

 Ensure compliance with all GXP guidelines for conduct and monitoring of GxP studies to meet regulatory requirements and enable use of data globally

 May act as an Investigator and/or Study Director in GxP studies by developing protocols and reports in collaboration with Sponsor’s Representatives and Global Development teams

 Design, review and make recommended changes to scientific protocols and procedures

 Conduct and report studies according to agreed team metrics

 May be responsible for the conduct of complex studies for the evaluation of efficacy and safety of compounds and assisting in the interpretation of these studies

 Undertake annual reviews of Standard Operating Procedures in conjunction with other Study Management personnel.

 Manage studies, documentation and work according to, and in compliance with, external and internal guidelines (e.g. SOPs, VICH, FDA, OECD, GxP, HSE and Animal Welfare Code of Practice)

 Assist other line functions as required to complete study tasks

 Present results to team or project meetings as required

 Collaborate with other associates to facilitate knowledge exchange. Assist with training and coaching peers as required

 Assist with the identification, communication and planning of resource requirements

 Assist with planning activities within the Study Management team to determine operational priorities – ensuring continuous improvement and efficiency across the teams resources – people, equipment and framework

 Perform any other duties or serve in such other capacity as may be determined by Company management and agreed upon within capabilities

Seek opportunities to enhance Study Management system processes

51138BR



Minimum Qualification (education, experience and/or training, required certifications):


 Bachelor’s Degree or equivalent in related discipline, preferably science or analytics

Science based background essential (minimum 5 years’ experience)

 Extensive experience in Monitoring requirements for GCP studies

 Broad scientific or technical knowledge in a specific area

 Adequate understanding of research and/or development processes in own function

 Adequate knowledge of products, parasites (including diagnosis) and disease

 Advanced knowledge of laboratory and/or technical tools

 Extensive knowledge of GCP, GLP and non-GxP studies

 Good presentation skills and scientific/technical writing skills

 Physically capable and skilled in handling animals

 Experienced in handling chemicals, ideally holding Chemcert accreditation

 Effective time management allowing completion of business critical tasks as required

 Initiative in suggesting/developing process changes to improve business efficiency

 Enthusiasm and energy for the role with a strong drive for achievement

 Effective execution strategies demonstrated across multiple projects

 Attention to detail, ability to thoroughly review data and documents/reports

 Strong accountability to deliver upon timelines for task, assignments and/or objectives

 Ability to build effective, trusting business connections quickly and work collaboratively with local and global colleagues across cultural, language and time zone barriers

 Ability to work effectively as a team or independently

 Ability to handle several projects simultaneously

 Good organizational and planning skills with a focus on delivering results

 Compliance with quality systems and standards

Other Information:

 Ability to work additional hours as required

 Fluency in English is essential

 The facility has no access to public transport so a driver’s licence and car is required