Project Manager

Project ManagerThe Project Manager is primarily responsible for the planning and management of all contracted responsibilities for assigned projects. Act as primary contact between Novotech and client. Leads and oversees the execution of clinical projects in accordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. Project Manager is responsible for the overall project deliverables, leading the internal team and the financial performance of the project.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.Project Managers are expected to have a solid understanding of the drug development and clinical trial process, the role and workings of a Clinical Research Organisation (CRO), ICH GCP, international and local regulatory requirements.PMs are expected to contribute to process improvement initiatives.Responsibilities:Project ManagementDetermine 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.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.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. 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.GeneralEnsure 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).Minimum 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.