Project Manager -Oncology

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.
• 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.
• Select and manage investigational sites in order to meet client objectives and timelines.
• Identify and evaluate investigational sites according to study requirements. Collaborate with the Novotech Clinical Operations and Regulatory Teams to ensure high quality ethics & regulatory submissions are made and approval obtained accordingly to meet study timelines for study set up.
• 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.
• 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. The 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.

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, including Associate Project Manager or equivalent.
• CRO experience is advantageous.