Project Manager - EU

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. Ensure appropriate training of investigational site personnel in the study and regulatory requirements for running the study. Organise and participate in Investigator Meetings as required by the client, including drafting and participating in presentations. 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. Ensure safety reporting procedures are clearly documented and followed. Ensure sites & CRAs are well trained and supported in order to provide high quality study data. Ensure sponsor timelines are met with regards to monitoring, eCRF completion and query resolution. 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. Ensure Investigational Product (IP) is being received, stored, returned/destroyed and managed according to ICH GCP and study requirements. On completion of all study requirements, ensure all study issues are resolved, including reconciliation and disposition of the IP. Ensure study is appropriately archived. Ensure audit / inspection readiness at project/country/site level and prepare audit/ inspection responses in collaboration with cross-functional clinical study team.

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.

Ensure appropriate training of investigational site personnel in the study and regulatory requirements for running the study. Organise and participate in Investigator Meetings as required by the client, including drafting and participating in presentations.

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.

Ensure safety reporting procedures are clearly documented and followed.

Ensure sites & CRAs are well trained and supported in order to provide high quality study data. Ensure sponsor timelines are met with regards to monitoring, eCRF completion and query resolution.

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.

Ensure Investigational Product (IP) is being received, stored, returned/destroyed and managed according to ICH GCP and study requirements.

On completion of all study requirements, ensure all study issues are resolved, including reconciliation and disposition of the IP. Ensure study is appropriately archived.

Ensure audit / inspection readiness at project/country/site level and prepare audit/ inspection responses in collaboration with cross-functional clinical study team.

Client Interface Apply knowledge & experience to make study decisions on behalf of the Client, according to the sponsor’s delegation. Will be the primary contact with the client. Act as facilitator between client, Novotech project team and clinical sites. Communicate sponsor needs to sites and represent the needs of the local sites to the Sponsor. Ensure the sponsor has a clear understanding of the requirements of a sponsor from a local regulatory perspective. Provide regular written and verbal updates on study progress to the sponsor, including study status updates and trackers. Participate in client meetings/teleconferences as required. Keep client updated on risks and issues including proactive risk management and issue resolution strategies.

Apply knowledge & experience to make study decisions on behalf of the Client, according to the sponsor’s delegation.

Will be the primary contact with the client.

Act as facilitator between client, Novotech project team and clinical sites. Communicate sponsor needs to sites and represent the needs of the local sites to the Sponsor.

Ensure the sponsor has a clear understanding of the requirements of a sponsor from a local regulatory perspective.

Provide regular written and verbal updates on study progress to the sponsor, including study status updates and trackers. Participate in client meetings/teleconferences as required.

Keep client updated on risks and issues including proactive risk management and issue resolution strategies.