• Determine project feasibility, considering the needs of the sponsor as required to assist Business Development.
• Actively provide guidance and review scope of work, responsibilities, timelines and quality of deliverables.
• Understand the requirements of the Project Agreement and ensure Novotech performs these services to the required standards. Understand the inherent risks of the project and collaborate with management to ensure appropriate contingencies are initiated.
• Ensure set up and maintenance of operational project plans, timelines & study tracking tools (such as CTMS), and eTMF, as required.
• Work with the Vendor Manager to assess, appoint and manage study vendors to ensure the study is adequately supported, e.g. central laboratory, drug distributors, IRT providers.
• Coordinates workstream and cross functional project teams, such as Clinical, Regulatory, Medical, Biometrics and Pharmacovigilance.
• Perform review of protocols, eCRFs, study specific forms and process, as per the requirements of the project.
• Set up and management of the Novotech project team, including Novotech alliance partner vendors.
• Liaise with Resourcing to ensure adequate resourcing of the project team to meet the needs of the project.
• Ensure team members are adequately trained on the project requirements.
• Motivate and manage the project team to ensure study responsibilities are performed in accordance with the study protocol and regulatory requirements and that project objectives & timelines are met.
• Actively monitor the progress of the study. Ensure the study team, Novotech Management, sites and client are regularly updated with regards to study progress and issues.
• Work collaboratively with Associate Project Managers in study management, appropriately delegating study management tasks according to experience and providing guidance and oversight of the same.
• Manage the study budget and revenue according to the Master Services Agreement and Project Agreement.Adjust ongoing revenue forecasts based on study progress.Ensure the project meets the realisation and profitability target.Communicate to management any changes in the study procedures/progress which significantly impact on revenue.Ensure changes in scope are recognised by the client and change orders are initiated and prepared in collaboration with Business Development ahead of work commencing.
• Selection and management of investigational sites in order to meet client objectives and timelines. Specific duties include:Identify and evaluate investigational sites according to study requirements.In collaboration with the Novotech Clinical Operations and Regulatory Teams, ensure high quality ethics & regulatory submissions are made and approval obtained accordingly to meet study timelines for study set up.Ensure appropriate training of investigational site personnel in the study and regulatory requirements for running the study. Organise and participate in Investigator Meetings as required by the client, including drafting and participating in presentations.Manage study logistics to ensure that all sites maintain adequate supplies to perform the study.Actively manage subject recruitment to meet study targets. Take action to activate and encourage recruitment and retention. Promptly investigate poorly recruiting or retaining sites and propose strategies to improve site performance to management & client. The Project Manager is responsible for instigating recruitment initiative should recruitment be delayed.Review visit reports, and ensure the trial is being conducted according to the protocol, GCP & regulatory requirements and to ensure consistency of training, monitoring and study procedures across sites. Ensure all site issues are appropriately addressed and escalated where necessary.Ensure safety reporting procedures are clearly documented and followed.Ensure sites & CRAs are well trained and supported in order to provide high quality study data. Ensure sponsor timelines are met with regards to monitoring, eCRF completion and query resolution.Work with Data Management (client or Novotech) to coordinate clinical and data management activities to meet study objectives.Work with Pharmacovigilance (client or Novotech) to coordinate safety management activities to meet study objectives. Project Manager may be responsible coordinating the Safety Review Committee (SRC), per the project scope.Ensure set up and maintenance of (e) TMF and in-house site files as per the SOPs. Ensure essential documents for site activation are reviewed and approved as required by the client and Novotech SOPs prior to IP release. Ensure ongoing maintenance of the (e) TMF throughout the study.Ensure Investigational Product (IP) is being received, stored, returned/destroyed and managed according to ICH GCP and study requirements.On completion of all study requirements, ensure all study issues are resolved, including reconciliation and disposition of the IP. Ensure study is appropriately archived.Ensure audit / inspection readiness at project/country/site level and prepare audit/ inspection responses in collaboration with cross-functional clinical study team.
• Client InterfaceApply knowledge & experience to make study decisions on behalf of the Client, according to the sponsor's delegation.Will be the primary contact with the client.Act as facilitator between client, Novotech project team and clinical sites. Communicate sponsor needs to sites and represent the needs of the local sites to the Sponsor.Ensure the sponsor has a clear understanding of the requirements of a sponsor from a local regulatory perspective.Provide regular written and verbal updates on study progress to the sponsor, including study status updates and trackers. Participate in client meetings/teleconferences as required.Keep client updated on risks and issues including proactive risk management and issue resolution strategies.

General:

• Ensure adherence to Company policies, SOPs and procedures and be quality minded in performance of duties.
• Assist in the review and development of SOPs and processes. Identify areas of inefficiency in process and make recommendations to management for improvements.
• Participate in activities of the project management group, as required.
• As requested, and in collaboration with the Business Development (BD) group coordinate feasibility information gathering.
• Identify and highlight opportunities within own projects to expand business collaborations.
• The Project Manager may be asked to participate in Bid Defence Meetings.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties and performance of the study team, presents a positive professional image of the company.
• Represent Novotech at industry forums (conferences, professional association, committee work, international investigator meetings).

Qualifications & Experience:

• Graduate in a clinical or life sciences related field.
• Relevant experience/qualifications in allied professions may also be considered.
• At least 5 years' experience within the clinical research industry and previous project management experience, including Associate Project Manager or equivalent.
• CRO experience is advantageous.

We offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

You must have full unrestricted working rights in Australia to be considered for this role.

We unfortunately cannot provide sponsorship for this role.

Novotech seeks an experienced Project Manager to lead clinical study delivery in Australia, working in a hybrid setup. You will coordinate cross-functional teams, manage scope, timelines and budgets, and ensure adherence to ICH GCP and regulatory standards.

The role requires a life sciences graduate with 5+ years in clinical research and project management; CRO experience is advantageous. You will liaise with sponsors, vendors and sites to drive study success and profitability.

The Senior Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned clinical projects. Act as primary contact between Novotech and client. Ensure that clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs and the Project Agreement. Project Manager is responsible for the overall project deliverables, leading the internal team, including sub-contractors and the financial performance of the project.

Senior Project Managers are responsible for the delivery of the project from site selection through to Close out of the study including all deliverables within scope. The Project Manager is responsible to identify and evaluate potential risks and develop risk management plans to mitigate this risk.

Senior Project Managers (SPMs) are expected to have a sound understanding of the drug development and clinical trial process and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements. SPMs are expected to contribute to process improvement initiatives. SPMs can manage full-service, multi-country and more complex projects including those with multiple vendors.

SPMs may be required to mentor junior staff and are expected to contribute to departmental activities and process improvement initiatives.

Novotech is seeking a Senior Project Manager to plan and manage all contracted responsibilities for assigned clinical projects. You will act as the primary contact between Novotech and the client, ensure trials are conducted in accordance with ICH GCP guidelines and local regulatory requirements.

You will oversee project deliverables, lead internal teams and sub-contractors, and monitor the financial performance of the project from site selection through close-out.

The Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client's expectations.

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
• Distribute start up related documents to local regulatory start up teams.
  • Oversee customization of core start-up documents to local requirements.
  • Ensure preparation and distribution of core contract and budget templates to applicable team members.
  • Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.
  • Oversee site activation package compilation and approvals.
• Proactively identify any risks to start up and Escalate to Project Manager. Develop RSU mitigation plans.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.
• Serve as a client's contact for regulatory start up related items.

Experience and Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model,so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.
• Ability to gain insights and make proactive decisions quickly.
• Culture that fosters partnership and collaboration, where every voice is heard and valued.
• Ongoing support from senior stakeholders and leadership team.

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model,so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.

• Ability to gain insights and make proactive decisions quickly.

• Culture that fosters partnership and collaboration, where every voice is heard and valued.

• Ongoing support from senior stakeholders and leadership team.

• Job Identification 3885
• Job Schedule Full time
• Locations Level 13, 440 Collins Street Melbourne, Victoria, 3000, AU