29 days old

Study Monitor

Sydney, NSW 2000
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Study Monitor
New South Wales
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. Elancos 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 Sponsors 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


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

Bachelors 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 drivers licence and car is required

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  • Science
Posted: 2019-08-21 Expires: 2019-10-19

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Study Monitor

Sydney, NSW 2000
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