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
Senior/Clinical Research Associate
Are you passionate about working on innovative programmes in oncology, rare disease, cardiovascular, and other therapeutic areas partnering with a world-renowned top 5 pharma? Great, because we’re hiring!
We’re looking for innovative clinical research professionals just like you to join our global clinical operations teams across Auckland and Christchurch.
- Perform site selection, initiation, monitoring and close-out visits and work with sites to adapt, drive and track subject recruitment plans
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administer protocol and related study training to assigned sites and establish regular lines of communication
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
- Collaborate and liaise with study team members for project execution support as appropriate.
- Bachelor’s degree in Life Sciences or other scientific/nursing disciplines is essential
- Minimum of 2 years independent site monitoring experience as a CRA
- CRO or Pharmaceutical experience is highly desired
- Ability to travel which will involve travelling to the North or South Island
- Extensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is required
- Oncology experience is highly desired
- Experience working with a Single Dedicated/FSP Sponsor as a CRA is desired
What is in it for you?
- A competitive base salary, generous car and health allowance, an annual bonus, flexible working, lifestyle and community days, regular social events, breakfast staples and fresh fruit provided, close to public transport, Global mobility opportunities and a Management team dedicated to taking you to where you want to go
- You will have the opportunity to build a career in a supportive environment, work with Industry leading Pharmaceutical companies and inspiring thought leaders
- We celebrate your success, we celebrate our learning’s, we celebrate Healthcare. This is just the beginning.
If you wish to hear more about these positions or any other positions IQVIA is currently advertising, please apply using this link: https://iqvia.wd1.myworkdayjobs.com/IQVIA/job/Auckland-New-Zealand-AUC1/Senior—Clinical-Research-Associate_R1129573
Closing date for applications is: 31st August 2020
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