Project Manager

Novotech

Australia
Permanent
Full-time

13 days ago

Job Description:About the roleProject Managers are responsible for the delivery of the project from site selection through to the close out phase (including the CSR if applicable). The Project Manager is responsible for identifying and evaluating potential risks and to develop risk management plans to mitigate this risk.Do you have Clinical Research experience and worked on gene therapy?Responsibilities

Determine project feasibility, considering the needs of the sponsor.
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.
Assess, appoint and manage study vendors to ensure the study is adequately supported, e.g. central laboratory, drug distributors, IVRS providers.
Coordinate workstream and cross functional project teams, such as Clinical, Regulatory, Medical, Biometrics and Pharmacovigilance

Experience and Qualifications

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.
CRO experience is advantageous as is experience with gene therapy
Experience in Net Suite will be added advantage.

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 applicationAbout Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.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.About the Team: Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

Novotech

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