06 Nov
|
Novatrials
|
Newcastle
06 Nov
Novatrials
Newcastle
About the role
We are seeking a Associate Project Manager to join Novatrials in Newcastle NSW on a full-time basis. This is an exciting opportunity to take on a pivotal role within our outpatient clinical trial unit, where you will support the management and coordination of clinical research projects from initiation through to completion. As a Associate Project Manager, you will work closely with our clinical operations team to ensure that clinical trials and research studies are delivered on time, within budget, and to the highest standards of quality and regulatory compliance.
This role is essential to our success in advancing medical research and bringing cutting-edge treatments to patients.
Key responsibilities
- Assist in the planning, scheduling and coordination of clinical research projects, including timelines, milestones and resource allocation
- Support the preparation and maintenance of project documentation, including protocols, regulatory submissions and study files
- Coordinate day-to-day study activities, including project meetings, follow-ups, action items, cross-functional workstreams, dependencies, and stakeholder updates.
- Oversee study start-up activities, including site activation tracking, essential document collection, ethics and regulatory submission support, study training coordination, and investigator and site readiness.
- Monitor project progress against established budgets and timelines, identifying and escalating risks and deviations
- Manage participant recruitment activities for studies within the allocated portfolio, including monitoring recruitment targets, enrolment progress, screening activity, and emerging recruitment risks.
- Support the recruitment and enrollment of study participants, working with recruitment team to meet recruitment targets
- Assist in the compilation, review and organisation of study data and documentation to ensure compliance with regulatory requirements
- Support quality assurance activities, including audits, inspections and compliance checks
- Liaise with sponsors, regulatory authorities and internal teams to ensure smooth project execution to facilitate effective project delivery
- Support vendor oversight by tracking deliverables and performance indicators, coordinating issue resolution, following up outstanding actions, and maintaining accurate vendor-related documentation.
- Contribute to continuous process improvement and the implementation of best practices in clinical research project management
What we're looking for
- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing, public health, project management, or a related discipline; equivalent relevant experience may be considered.
- Experience supporting clinical trials, clinical research operations, study coordination, project coordination, or a related healthcare or pharmaceutical environment.
- Working knowledge of clinical trial conduct, study documentation, Good Clinical Practice, research ethics, and applicable regulatory expectations.
- Ability to manage multiple priorities, maintain accurate trackers, follow up on action items, and support delivery against deadlines.
- Strong written and verbal communication skills, with the ability to work effectively with internal teams, external vendors, sponsors, and site personnel.
- Proficiency with Microsoft Office applications and project tracking tools; experience with clinical trial management systems, electronic Investigator Site File systems, or electronic data capture systems is desirable.
About us
Novatrials is a leading, private clinical trial centre that has been bringing new treatments and devices to the people of Newcastle since 2018. It is committed to increasing opportunities for the community to participate in high quality phase I-IV clinical trials involving new cutting-edge technology across a range of therapeutic areas including cardiovascular, rheumatology, endocrinology, dermatology, pain management, and infectious diseases Our mission is to bring cutting-edge medical treatments to regional Australians, expand community access to clinical trials, and facilitate the discovery of new life-saving therapies. We pride ourselves on our commitment to our values of respect, integrity, teamwork and excellence.
Apply now
If you are interested in this opportunity and believe you meet the requirements, we would like to hear from you. Please submit your CV, a cover letter outlining your relevant experience and interest in the role, and contact details for two professional referees. Join our team and make a meaningful contribution to advancing clinical research and improving patient outcomes.
📌 (Clinical) Associate Project Manager (Newcastle)
🏢 Novatrials
📍 Newcastle