Project Manager - EU

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.

• 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.
• Work collaboratively with Associate Project Managers in study management, appropriately delegating study management tasks according to experience and providing guidance and oversight of the same.
• 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.
  • 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.

• Ensure 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).

• 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.