Study Start-Up Manager (12-month maternity cover)

About us:

Celebrating over 30 years, CMAX is Australia’s longest running and most experienced clinical trial unit 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 400 staff, CMAX is a 78-bed clinical trials unit, with a database of more than 70,000 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 Chief Business Development Officer, the Study Start-up Manager (SSM) will be a fulltime position providing effective leadership in the planning and execution of start-up activities for awarded clinical trials enabling the conduct of high quality study conduct, consistent with CMAX Standard Operating Procedures (SOPs) and relevant regulations and guidelines. You will be responsible for the overall management of the study start-up activities at CMAX and delegate responsibilities as required.

The SSM will support information flow between Business Development, Clinical Operations and will coordinate the transition of newly awarded studies to the Clinical Project Management team.  They will liaise and maintain strong relationships with sponsors, CROs and their representatives. They will be actively involved in study start-up activities from the time of study award through to HREC/IRB approval, whilst leading, supervising and assessing the performance of direct reports

Key responsibilities include:

• Draft timelines for study start-up activities;

• Prepare and/or review key clinical study documentation including the Study Protocol and Participant Information Form/Informed Consent Form;

• The preparation and tracking of Human Research Ethics Committee/Independent Review Board (HREC/IRB), Research Governance submissions and other regulatory documentation;

• Participate in initial discussions/meeting with study sponsors and or CROs, as required;

• Work with Sponsors, CROs and Investigators to respond to IRB/HREC comments, amending key documents as required and enabling timely submission for approval;

• Ensure correct versions of study documentation are distributed for review by key study personnel within the required start-up timelines and that feedback is collated and communicated in a consistent and complete manner;

• Review and prepare study legal agreements including Confidentiality Agreements, Letters of Intent, Clinical Trial Research Agreements, work orders and sub-contracts, and tracking of legal agreement execution as delegated by the Chief Business Development Officer or relevant CMAX Manager;

• Provide relevant start-up and handover information (including key study start-up milestones) to CMAX clinical staff to enable smooth start-up of studies, including the allocated CMAX study team;

• Create and review systems with a view to optimising start-up operations;

• Provide assistance and study support to other clinical staff when required as directed by the relevant CMAX Manager;

• Undertake responsibility for implementing 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 a productive and high performing team;

• Actively contribute to the identification, design and delivery of staff training and development within own team and across the organisation more broadly;

• In collaboration with the Chief Business Development Officer and other relevant stakeholders, establish effective targets and ensure these are monitored, reported, achieved and/or modified as agreed.

About you:

• Demonstrated strong working knowledge of standards, procedures and regulations relating to the conduct of clinical studies, including ICH GCP;

• Demonstrated and successful experience in clinical research, particularly in reviewing key study documentation and preparing ethics submissions, or in clinical trial operations;

• Prior team management experience is highly desirable;

• 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;

• Proven ability to demonstrate sound, evidence based judgement and decision-making skills and the ability to solve problems in a constructive manner.

Why work at CMAX?

At CMAX, you’ll have the opportunity to make a meaningful contribution to the development of new medicines and healthcare technologies while working alongside an experienced and collaborative team.

• Make an impact through world-leading clinical research;

• Lead and develop a high-performing study start-up team;

• Gain exposure to diverse early-phase and first-in-human studies;

• Drive innovation and process improvement across study start-up.

If you enjoy a challenge, working in a fast-paced environment and have an interest in innovation of healthcare, please apply by attaching your application letter and CV via the Apply Now function. Applications will close on Sunday 27 September 2026.

Only candidates who have the right to work unrestricted in Australia will be considered for this position. Please note while this position has flexible working arrangements, there are some onsite requirements and applicants must be located in Adelaide, South Australia.

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.