1+ months

Study Manager

Sydney, NSW 2000
47716
Study Manager
SYDNEY
New South Wales
Asia/Pacific
Australia
Local
Elanco (a Division of Eli Lilly and Company), 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
Functions, Duties, Tasks:
  • Act as an Investigator and/or Study Director in GxP studies by developing protocols and reports in collaboration with Sponsors Representatives and Global Species Development teams
  • Responsible for the conduct of complex studies for the evaluation of efficacy and safety of compounds and assisting in the interpretation of these studies
  • Planning, performing, interpreting and reporting results of field and laboratory efficacy and safety studies in both livestock and companion animals according to agreed team metrics
  • Designing, reviewing and making recommended changes to scientific protocols and procedures.
  • Ensuring timely availability of study protocols and study plans for the AEC (Animal Ethics Committee) and co-operating with the Animal Welfare Officer, to ensure the highest standards of animal welfare are maintained
  • Conducting and reporting studies according to agreed team metrics
  • Undertaking annual reviews of Standard Operating Procedures in conjunction with other Study Management personnel (if necessary)
  • Managing 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)
  • Managing the Global Database for all study inputs/records
  • Assist other line functions as required to complete study tasks
  • Presenting results to team or project meetings as required
  • Collaborating with other associates to facilitate knowledge exchange. Assist with training and coaching peers as required
  • Assisting with the identification, communication and planning of resource requirements
  • Assist with planning activities within the Efficacy team to determine operational priorities ensuring continuous improvement and efficiency across the teams resources people, equipment and framework
  • Performing any other duties or serve in such other capacity as may be determined by Company management and agreed upon within capabilities
  • Ensuring compliance with all GxP guidelines for conduct and monitoring of GxP studies to meet regulatory requirements and enable use of data globally
Seeking opportunities to enhance Study Management system processes 47716BR
  • Bachelors Degree or equivalent in related discipline, preferably science or veterinary degree Science based background essential (minimum 5 years experience for BS or entry level for MS)
  • 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
  • Knowledge of GCP, GLP and non GxP
  • Good presentation skills and scientific/technical writing skills
  • Physically capable and skilled in handling animals
  • Experienced in handling chemicals, ideally holding Agsafe 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 undertake local, interstate and international business travel
  • Ability to work additional hours as required
  • Fluency in English is essential
Travel requirements up to 10%
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Categories

Industry

  • Science
Posted: 2019-03-06 Expires: 2019-06-02

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 Manager

Lilly
Sydney, NSW 2000
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