CMAX Clinical Research
Clinical Project Manager (Remote)
Clinical Project Manager | CMAX Clinical Research |Australia
About us:
Operating for more than 30 years, CMAX is Australia’s longest runningand most experienced clinical trial units conducting successfulworld-leading research for local and international clients, specialising ina range of early-phase trials and first-in-human studies.
We are proud to be a key contributor in the advancement of global...
Clinical Project Manager | CMAX Clinical Research | Australia
About us:
Operating for more than 30 years, CMAX is Australia’s longest running and most experienced clinical trial units conducting successful world-leading research for local and international clients, specialising in a range of early-phase trials and first-in-human studies.
We are proud to be a key contributor in the advancement of global medicines and technologies – from vaccines and pain control to early warning bio-devices and hormone replacement therapies, these are just a few of the many research areas for which CMAX has provided clinical trial services.
Employing more than 300 staff, CMAX is a 78-bed clinical trials unit, with a database of more than 45,000 clinical trial participants, and utilising state-of-the-art facilities, we are primely positioned, opposite the Royal Adelaide Hospital and part of the Adelaide BioMed City precinct.
About the role:
Reporting to the Senior Clinical Project Manager, the Clinical Project Manager will provide effective leadership in the planning, organising, communicating, implementing, monitoring, evaluating and managing of Study Team objectives to ensure that all clinical studies are conducted to a high standard of quality consistent with our CMAX Standard Operating Procedures (SOPs) as well as the relevant industry regulations and guidelines.
Key responsibilities include:
- Undertake responsibility for implementing clinical research systems and initiatives that are compliant with ICH GCP requirements;
- Manage and monitor the performance of supervised staff members through the provision of regular and constructive feedback, identifying and facilitating training and development needs, providing coaching support and building productive and high performing teams;
- Undertake the planning of and participate effectively in sponsor study initiation meetings;
- Undertake feasibility analyses of proposed clinical trials including the development of budget proposals and risk management strategies;
- Manage liaisons with sponsor representatives with respect to potential study placements;
- Develop detailed project plans for all assigned clinical trials, including recruitment strategy, project timelines, data management, study plans, decision-making grid, escalation process and any other factors critical to ensuring that the trial is conducted to a high standard;
- Design and/or review all key clinical study documentation including the Study Protocol, Study Information Form/Informed Consent Form and other source documentation;
- Manage the preparation and tracking of Institutional Ethics Committee/Independent Review Board (EC/RB) submissions and documentation;
- Manage all activities associated with the handling and accountability of study drugs, the handling and tracking of adverse event reporting and the processing, storage and tracking of biological samples;
- Ensure that appropriate study milestones and targets are met on time and within budget and that where risks to achievement are identified, these are reported to the Clinical Operations Manager in a timely manner;
- Ensure that study team members are provided with appropriate guidance, support and supervision throughout the conduct of assigned studies and that where performance deficiencies are identified, these are managed in a timely and appropriate manner;
- As a member of the Management Team, actively promote a commitment to excellence and continuous improvement across the organisation.
About you:
- Tertiary qualifications, or equivalent relevant training and experience within a health or science related discipline;
- Demonstrated working knowledge of ICH/GCP and the local regulatory framework;
- Proven experience in clinical research;
- High level of interpersonal skills, including verbal and written communications skills, negotiation and influencing skills and the ability to engage positively with a diverse range of staff and stakeholders;
- Demonstrated and well-developed project management skills as they apply to the effective conduct of clinical studies;
- Experience in developing effective project plans, including the establishment and management of project timelines, budgets, staff, risks, targets and other relevant critical success factors;
- Demonstrated competence in the personal attributes of leadership, initiative, flexibility and attention to detail;
- Sound understanding of the principles and practices applying to quality and continuous improvement within a clinical research environment.
This role requires flexibility for being contactable and available to undertake some work outside of business hours, to ensure participant safety, smooth conduct of each trial and to support our global customers in various time zones. This is a site-based position with limited work from home scope.
If you are inspired to be a part of a company making a difference in tomorrow’s health care and enjoy leading projects in a fast-paced dynamic environment, then please apply by attaching your application letter and CV via the Apply Now function, applications close on Friday 25 October 2024.
Only candidates with approved rights to work full time without restrictions in Australia will be shortlisted for this role.
Please note that we may be conducting interviews during the advertisement period and retain the right to withdraw the advert should we select a successful applicant prior to the closing date.
