Description The 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

Responsibilities:

Project management

- 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.

- 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.

- Ensure team members are adequately trained on the project requirements.

- 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.