About the business
Pharmaceutical Solutions is a dynamic and growing New Zealand and Australian based independent CRO, offering personalised clinical research management and regulatory services to local and international biotechnology and pharmaceutical industry.
We are proud to promote quality clinical research in our region and of our contribution to improving people’s health and wellbeing.
Our team has global experience with large pharmaceutical, medical device and biotechnology companies ensuring expertise in a wide variety of therapeutic areas.
About the role
We are looking for an experienced Senior Project Manager who is located in either New Zealand or Australia who would be able to ensure that the projects under their responsibility, are delivered on time, within budget, and to the agreed scope while maintaining the appropriate industry i.e. ICH GCP, sponsor and PSL quality standards.
The role also requires the following:
- Management of assigned project team, provide training where needed and continuously review resource allocation of tasks to ensure workload remains within scope
- Utilises delegation and negotiation skills with regards to project tasks, to obtain maximum productivity and team involvement
- Communicates regularly with internal and external team members regarding study status and provides timely notification to all appropriate parties with deviations from timelines and/or deliverables
- Organisation and facilitation of project meetings both within PSL and externally with the sponsor, vendors etc
- Manages all associated vendors for assigned projects and performs routine assessments of deliverables
- Develop, review and edit of project plans to assure consistency with project goals
- Provide financial management activities for one or more project budgets as well as
execution of Change Orders
- Manages project timeline regularly sharing this information with project teams and clients
- Actively identifies, manages, and mitigates any project risks and communicates to internal and external parties as appropriate
- Involvement in the review and editing of SOPs and creation of Project Management Tools that will benefit the wider company
Contribute to Bid Defence activities and budget creation, review prior to project award
Benefits and perks
- Challenging and interesting assignments
- Supportive colleagues
- An environment where you are valued, and initiative is encouraged
- Opportunity to be flexible
- Exposure to other parts of the business
- Opportunity to mentor/train colleagues
- Competitive salary and benefits package.
- Career progression both in NZ and Australia
- NZ head office located in the Britomart Precinct in Auckland
Skills and experience
Bachelor’s degree, equivalent or higher qualification within Biomedical Science, Pharmacology, Nursing or a relevant life sciences discipline.
Must be an AU or NZ Resident.
- Excellent interpersonal skills and leadership potential
- Maintains a positive, results oriented work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced and objective manner
- Excellent interpersonal, verbal and written communication skills
- A flexible attitude with respect to work assignments and new learning
- Critical thinking to evaluate information gathered from multiple sources, reconcile conflicts, and decompose high-level information into details
- Client focused approach to work, meeting and exceeding client expectations – thinking outside the square
- Acts as a resource for colleagues and staff members when necessary
- Problem resolution skills; ability to analyse and solve a range of simple and complex problems
- Demonstrates knowledge of the organization, processes, and clients
Knowledge & Experience:
- Minimum 5 years of relevant experience in Clinical Research Project Management.
- Experience and knowledge of working in a variety of therapeutic areas
- Experience of managing International clients from a CRO environment
- Experience in selecting and managing external service providers
- Strong analytical, organisational, communication and numeracy skills
- Self-motivated, able to work independently and able to assume responsibility in a professional manner
- Ability to prioritize workload with attention to detail
- Excellent in verbal and written English language
- Proficient in Microsoft Office 365, Excel and MS project
- Experience working with a range of clinical trial systems
Research Director, Ngati Porou Hauora, Te Rangawairua O Paratene Ngata Research Centre, East Coast & Gisborne
With continued expansion, the opportunity has arisen to appoint a Research Director.
Te Whiwhinga mahi | The opportunity
Reporting to the Chief Executive, this newly created full-time position is key to leading our research services forward whilst continuing to provide seamless, high-quality research services and outcomes with our communities and for key stakeholders.
The Research Director will lead and deliver Te Rangawairua O Paratene Ngata Research Centre in the following;
- Ensuring all research and evaluation projects involving Ngāti Porou Hauora (NPH) patients, communities and/or staff are coordinated in accordance with the NPH Board’s Research Policies and Procedures.
- Developing and maintaining relationships with key stakeholders and the wider community, so that the central purpose of the organisation is achieved.
- Providing advice on a range of research related issues (ethical issues; best research and evaluation practice; financial and legal issues; clinical and research workforce development; and other health service improvement issues/opportunities).
- Identifying and applying for research funding.
- Facilitating research collaborations across NPH and its communities, including with universities and other organisations.
He kōrero mōu | About you
Our ideal candidate will have understanding of tikanga Māori and the credibility to lead a Kaupapa Māori research centre. Alongside this will be a strong background in research, with experience in the leadership of health research and evaluation initiatives and multidisciplinary teams. You will also demonstrate solid knowledge and application of best practice in Māori health research and Good Clinical Practice, as well as strong financial, budget and project management skills. Experience in managing change, developing research services and working collaboratively is also valuable.
For more detailed information about the responsibilities and requirements of the role, please review the Position Description.
Ngā āhuatanga kei a mātou | What we offer
Kia tu pakari, kei tua o kapenga
“The next generation living longer than the last”.
The NPH vision is at the forefront of the mind of the organisation as we work towards the shared mission to be responsive to the needs of our people.
You will enjoy working collaboratively and contributing to research that is truly life changing for future generations.
Me pēhea te tuku tono | How to apply
Applications should be submitted online, before the closing date of Friday 27 November 2020 and include an up to date CV and cover letter outlining what strengths you will bring to this role.
If you have any questions about this role, please contact Frances King firstname.lastname@example.org
Cure Kids is New Zealand’s leading funder of child health research outside of the government. Cure Kid’s mission is to enable research to transform the health of children in New Zealand and the Pacific.
Reporting to the Director of Research & Innovation, this contract role will initiate, foster and expand research partnerships, investments, and collaborative networks in line with Cure Kids’ mission to enable research to transform the health of children.
Key responsibilities include:
- Analysing Cure Kids’ stakeholder network and creating a structured plan, including managing existing relationships and engaging with new partners (such as Māori agencies and community groups, international organisations, and healthcare providers in the private and public sectors)
- Catalysing research collaborations and multidisciplinary networks
- Identifying potential funders, negotiating agreements and securing funding for major initiatives
- Scoping possibilities for new initiatives based on priority disease areas, alignment with potential co-funders and potential to generate impact
- Assisting researchers to develop tenders for contract research aligned with Cure Kids’ mission
- Supporting Cure Kids’ projects in Fiji and the Pacific Islands, as required, to deliver on agreed research milestones
The ideal candidate will hold a tertiary qualification in science, commerce, policy, law, or the health sector and have at least 3 years’ relevant experience within a university or the not-for-profit sector. You will have exceptional written and oral communication skills, strong attention to detail, and business acumen, with strength in negotiating contracts.
The role will best suit a creative problem-solver, who is able to work methodically, both independently and collaboratively as part of a team and who’s not afraid of rolling their sleeves up for this wonderful cause.
This is a full-time contract role for one year. The Cure Kids offices are in Eden Terrace, Auckland and there is flexibility to work from home for part of each week.
Please follow this link to the job description:
If you have the desire to support the life-changing work of Cure Kids then please email an updated CV with a cover letter addressed to Sarah Woodhams, Execucare, outlining your experience against the core competencies in the job description and tell us why you would want to work for Cure Kids. Please note that applications will be assessed as they are received.
Applications close Wednesday 9 December 2020
For more roles like this, please visit our website at www.execucare.com or register as a candidate with an updated CV.
Recognised recently as a Top CRO by Life Science Leader, Premier Research is a medium sized, full service, global CRO with circa 1,500 employees worldwide, perfectly positioned to be big enough to help, yet small enough to care. We help highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. Premier takes on the most challenging areas of study, with a special focus on unmet needs in such areas as Oncology, Neurology, Paediatrics, Rare Diseases and Medical Devices, supporting the needs of smaller Pharmaceutical organisations and Biotech companies. There is real opportunity to work across multiple clients on a variety of unique and interesting studies.
Continued growth means we are excited to have the chance to add a Senior Clinical Research Associate to our team. Apart from the opportunity to enhance your skills and expertise in an autonomous, permanent, home-based role, we will equip you with:
- An opportunity to develop with support of our tailored learning & development program – the Academy
- A chance to utilize your experience by supporting feasibility and project planning activities
- Great work-life balance allowing you to focus on the quality of your deliverables
At Premier you will be visible, recognized and you will truly make an impact! We have an aspiring and empowering culture and strive to work globally as #oneteam, so you can count on a support of the smartest minds in the industry! Individual approach and cooperation with locally based Management Team will help you shape your career, steer it in the desired direction and grow along with the company!
This is an exciting opportunity to join a dynamic and innovative CRO. As a Senior Clinical Research Associate, you will be responsible for performing clinical trial monitoring activities and have some involvement in start-up activities in compliance with trial protocol, ICH-GCP, applicable local laws and regulations, company policies and quality standards. You will manage study-site activities to ensure collection of accurate clinical data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support. This role will be fully home-based in one of New Zealand major cities, supported by an Australian line manager.
You’ll be accountable for:
- Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Scheduling site visits for monitoring as required by protocol monitoring visit windows.
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
You’ll be responsible for:
- Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Planning day-to-day activities for study monitoring and setting priorities by site.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- Working with the line manager and CM to ensure that visit metrics are maintained as required.
- Gauging the quality of clinical deliverables and addressing quality issues with team members.
- Providing accurate and timely trip reports and records of hours worked.
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information.
- Participating in Investigators’ Meetings as assigned by Project Managers.
- Maintaining contact with investigator sites via telephone calls between visits.
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
You’ll also contribute by:
- Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.
- Participating in training offered to increase therapeutic knowledge and keeping current with regulations and TGA guidance.
- In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
- Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
You’ll need this to be considered:
- Education: Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional
- Fluent verbal and written English
- Previous clinical research and independent site monitoring experience
- Working knowledge of New Zealand and international regulatory procedures, and monitoring activities
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
Imagine. Inspire. Innovate. Impact. With Us.
If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at email@example.com.
You must be eligible to live and work in New Zealand in order to apply for this role. Applications close 31 January 2021
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