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Novotech

Project Manager ECD

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The Associate Project Manager is primarily responsible for all aspects of study conduct in assigned countries/regions within larger multi-country projects and/or take full responsibility for regional management of key aspects of the project (e.g. vendor management) under the guidance of a (Senior) Project Manager. The APM will also support the Project Manager in the planning, management and execution of project management responsibilities. APMs will be required to back up Project Managers during absences for assigned studies, including primary contact with the client.

APM may also take on PM oversight for smaller scope studies in single countries and/or with limited number of sites.

APMs are expected to have a sound understanding of the drug development and clinical trial process, ICH GCP, international and local regulatory requirements.

What you will do:

The APM will work with the PM and act as a link between the PM and the local study teams, including LCRAs (where assigned) and CRAs, ensuring that clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs and the Project Agreement. The APM will undertake the following project specific activities.

Project Management

  • Understand the requirements of the Project Agreement and project scope in order to ensure Novotech performs these services to the required standards. Understand the inherent risks of the project and collaborate with the PM and management to ensure appropriate mitigation and contingencies are initiated.
  • Ensure appropriate setup, testing (if applicable) and maintenance of project reporting/tracking systems (e.g., EDC, IRT, CTMS etc.).
  • In collaboration with the study PM and Novotech Vendor Manager, contribute to the engagement of required study vendors, as delegated, including contracting and oversight of contracted deliverables as the study progresses.
  • Contribute to the development and implementation of project and operational plans and tools to adequately monitor project progress against key milestones, timelines and resourcing.
  • Assist PM to ensure team members are adequately trained on the project requirements by preparing content and/or facilitating project related training.
  • Assist PM with management of project budget and associated internal financial responsibilities (e.g. monthly revenue recognition and forecasting activities)
  • Ensure changes in scope are identified and raised with the PM and actioned accordingly. Identify opportunities to extend scope and increase revenue where appropriate.
  • Support country and site selection at study level through critical review of feasibility and site evaluation information and drive site selection activities within assigned countries/regions.

  • Support PM and CRA/CRA in management of investigational sites in order to meet client objectives and timelines.

    Specific duties include:

  • In collaboration with the Novotech Clinical Operations and Regulatory Teams, ensure local teams in assigned countries appropriately plan and prepare high quality IEC & Health Authority submissions, with approval obtained accordingly to meet study timelines.
  • Work with local study teams to ensure appropriate training of site personnel in the study and regulatory requirements

Client Interface

  • Provide back up for the PM for client management and communication, internal team management, project financial management etc. in PM absence.
  • Assist/back up PM in providing regular written and verbal updates on study progress to the sponsor, including study status updates and trackers. Participate in client meetings/teleconferences as required.
  • Assist PM in keeping client updated on risks and issues including proactive risk management and issue resolution strategies.

Where APM is acting as the primary PM (i.e. small scope projects, limited number of sites and/or single country),

  • APM will have overall project management responsibility and take the lead and ownership of all duties listed above at a project/country/site level.
  • In addition to the duties listed above:
  • Actively provide guidance and review scope of work, responsibilities, timelines and quality of deliverables.
  • 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.
  • 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.
  • Will be the primary contact with the client. Act as facilitator between client, Novotech project team and clinical sites. Communicate sponsor needs to site 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.
  • Oversight of assigned CRA(s)
  • Responsible for internal oversight/management of project’s financials. Manage the study budget and revenue according to the Master Services Agreement and Project Agreement

Minimum Qualifications & Experience:

  • Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.
  • At least 4+ years direct clinical trial experience working in various study phases (I, II, III) and stages (e.g. start-up, maintenance and close-out) with at least 3 years in a CRA or equivalent role.
  • Previous experience as a Lead CRA or Project Specialist with monitoring experience highly regarded.
  • Previous experience and competency in standard business procedures (SOPs, global regulations, CTMS). Previous matrix management and CRO experience 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.