The Associate Manager Clinical Operations is responsible for the line management, selection, training, coaching and performance management of the New Zealand Local Start-up team, including Contract Specialist, Country Activation Specialists (CAS) and Clinical Trials Coordinators (CTC-local). This could also include line management of Remote Site Monitors (RSMs) as the team continues to expand over time.
Focusing on end results to be achieved, uses metrics and key performance indicators to manage individual and team performance. May lead the Clinical Management team for a region or area, or may lead or contribute to initiatives that enhance Clinical Development/PPD business objectives.
Applications close – 17 September 2021
ICON plc is a world-leading healthcare intelligence and clinical research organsation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Clinical Research Associate II (CRAII)/Senior CRA | Auckland, New Zealand
- Office based role in our Auckland City office; parking available
- Minimum 2 years independent site monitoring experience required
- Global CRO or Biotech/Pharma CRA industry experience preferred
Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report
Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager
Assume additional responsibilities as directed by Project Manager (PM)
Dependent on level of experience you may assist in training and mentoring less expert CRA’s and/or lead CRA’s working on international projects
What you need
Minimum 2-3 years experience as a CRA I/ II required
Experience in phase I-III trials as a CRA, Oncology studies experience advantageous
Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
You will possess excellent written and verbal communication in English
Ability to produce accurate work to tight deadlines within a pressurized environment
You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license; this is dependent on Covid-19 measures
Preferably possess current and valid working rights in New Zealand and currently located in Auckland preferred due to Covid-19.
How to apply for the position
Register an application via the job posting link below
Applications close – 11 October 2021
Teletrials Project Manager
22.5 hours a week- 12 month fixed term
About the company
Working with some of the biggest international pharmaceutical companies, this organisation has a strong reputation for delivering high standard clinical trials. Delivering results to all parts of the globe, they are often at the forefront of pharmaceutical developments.
About the Role
This is a pivotal role in clinical research and trials. Working as part of a team, the Senior Research Physician provides direction and management throughout the trial. This includes setting the assessments and assisting with the organisation, through to subject selection, observation and problem management concluding with final discharge. Work 3- 4 days a week within normal business hours and have time for other interests.
- Lead research investigations
- Manage a team assigned to the clinical study
- Participate in the establishment of trials ensuring compliance and standard operating procedures are met
- Assess subjects for suitability and monitor them during the trial period
- Work as part of a team contributing to the establishment, accuracy and quality of the clinical trials
- Identify and deal with any problems that arise over the course of clinical trials.
- Liaise with subject’s GP or referring specialist through the trial process
- Assist with staff training when and if required
Skills & Experience
- Registered medical practitioner with a current practicing certificate and professional indemnity cover.
- Minimum of 3 years’ experience in clinical research as an Investigator
- Good understanding of Good Clinical Practice guidelines (ICH/GCP)
- Must have substantial post-graduate clinical experience.
- Previous experience in oncology, haematology, diabetes and cardiovascular disease would be beneficial
- Excellent communication skills both verbal and written
- Ability to work autonomously and as part of a multidisciplinary team.
- Be part of a well-respected team of clinical researchers
- Be involved in cutting edge product development working with global leaders in the pharmaceutical industry
- Work 4 days a week with no weekends
- Extensive training is offered and a regular CME/CPD is provided
Reference Number: 170867
This is a great role for a physician with a passion for process and protocol to be a part of the pharmaceutical future.
To apply online, please follow this link to our website: https://www.frontlinerecruitmentgroup.com/healthcare-and-medical-jobs/senior-research-physician/3258984
Alternatively for a confidential discussion please contact Deb Glen on +64 27 203 5661 quoting the reference number above.
Do you have expertise in, and passion for, Clinical Research? Would you like to apply your expertise to impact the effectiveness and medication of products in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
We’re investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.
We are a hard-working, fun, fast paced, encouraging, cake-loving (with free gym access) team! We are continuously evolving and adapting to build new and better ways of working across clinical research and development. We want to support each other to be as efficient as possible to drive work life balance. We are undergoing expansion and with so many roles locally and globally, we provide opportunities to drive your development and growth your way. The team has grown by 60% in just 2020 alone, and still growing. Our pipeline and projects are continuously growing, and we want you to join us!
What you’ll do
You are a self-motivated, proactive, and passionate individual focused on delivering quality outcomes in a fast-paced environment. The new Clinical Research Associate (S/CRA), initially on a contract basis, will be involved in effective site management across a number of high-profile studies as well as all aspects of the study from preparation, initiation, monitoring, and closure.
To be successful in this role you will have good knowledge of Clinical Study Management across monitoring, study drug handling and data management. You will ideally have experience working in a similar capacity, have excellent knowledge of international guidelines ICH-GCP, relevant local regulations and a basic understanding of the drug development process.
Essential for the role
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH‐GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Desirable for the role
- Ability to work in an environment of remote collaborators.
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Good analytical and problem‐solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk‐based monitoring approach including remote monitoring.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA). As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment. This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have seats available and we hope it’s yours.
- If you’re curious to know more then please reach out to Daniel Kim. We welcome your application
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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