Project Manager Early Phase at Novotech Global

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

0.0

Posted On

30 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Research, Vendor Management, Risk Assessment, Operational Planning, Cross Functional Coordination, Regulatory Compliance, Quality Assurance, Timeline Management, Scope Management, Feasibility Assessment, Team Collaboration, Data Management, Statistical Analysis, Medical Monitoring, Safety Solutions

Industry

Biotechnology Research

Description

About the Role The Project Manager – Early Phase is primarily responsible for the planning and management of all contracted responsibilities for assigned early phase projects and to act as the primary contact between Novotech and its clients. Responsibilities 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. Experience and Qualifications At least 5 years’ experience within early phase clinical research studies and previous project management experience, including Associate Project Manager or equivalent Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. CRO experience is advantageous. 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). Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. 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. .

Responsibilities

The Project Manager – Early Phase is responsible for planning and managing early phase projects while acting as the primary contact between Novotech and its clients. This includes determining project feasibility, managing timelines, and coordinating cross-functional teams.