To manage ongoing trials being undertaken on behalf of EUSA Pharma by 3rd Party Vendors, delivering the Clinical Development objectives and achieving clinical excellence through coordination of a multi-disciplinary team and CROs. The Clinical Project Manager will ensure the effective and efficient delivery of all operational aspects of any local and/or international clinical studies assigned to them through Clinical Study Management (Plan, Initiate, Conduct, Close and Report). Strong project management is required to ensure the studies are carried out in accordance with the appropriate quality standards, including ICH/GCP, and applicable regulations on time and within the agreed budgets.
Key Activities / Decision Areas
- To provide day-to-day operational management of vendors (e.g. CROs) to ensure delivery against contracted scope of work.
- To act as primary contact for the vendor, monitoring performance, identifying issues, and overseeing and co-ordination of corrective actions.
- To develop and execute appropriate site and vendor audits and implement quality plans.
- To ensure preparation of confidentiality agreements and contracts, liaising with legal as appropriate.
- To foster and develop a team approach to all activates associated with implementation of clinical studies.
- To participate in the selection of CRO and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set.
- To identify and implement SOPs, policies and other templates to ensure appropriate activity, documentation and tracking.
- To establish and define appropriate KPIs and associated measures to track and report on clinical operations activities.
- When leading any clinical project, to ensure regular and timely liaison with the Clinical Operations Manager. Provide regular and timely reports on all site performance changes including scope, schedules and resources.
- To contribute proactively to efficient operation of the Clinical Operations department and to systems, and processes being planned and implemented. To participate in the preparation, review, updating and training of SOPs.
- To chair internal and external meetings related to assigned clinical studies.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines for assigned projects, ensuring they are performed to the most rigorous standards of quality, within the agreed timeframes and budget.
- Provide operational input into the development and tracking of SMT goals.
- Provide regular updates to internal and external stakeholders.
- Ensure the clinical studies remain within agreed budgets.
- Prioritise and schedule all matters related to the clinical studies for which the Project Manager is responsible.
- To establish and maintain excellent professional relationships between the company and Key Opinion Leaders (KOL).
- To identify and gain approval for high quality investigators and study sites for the conduct of clinical studies.
- To ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the Regulatory and Pharmacovigilance Departments. To ensure that any important safety issues are discussed with appropriate departments and line management.
- To prepare and/or manage the production of all documents necessary to implement and monitor the study in a professional, high quality and timely manner.
Maintain procedural and regulatory requirements
- To review and recommend amendments to the study protocols, Investigator Brochure and Informed Consent Forms to ensure study feasibility and to plan and organise work schedules.
- To understand FDA, EMA and other regulatory authority requests for data quality and GCP.
- To ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the Regulatory and Pharmacovigilance Departments. To ensure that any important safety issues are discussed with appropriate department and line management.
- Participate in the preparation and review of clinical study reports as assigned; participate in the preparation and review of regulatory submission documents as needed, including IND/NDA submission, IND/NDA update and supplements and EuDRAC submissions or local requirements.
- Ensure that reporting of SUSARs is established and maintained for the duration of the study.
- Ensure regulatory green light is given prior to commencement of any studies.
- To identify areas of best practice and process improvements.
- Ensures study adherence to ICH/GCP, SOPs and local requirements.
- Excellent organisational and management skills
- Excellent verbal and written communication skills
- Good computer literacy
- Life Sciences higher educational level or other relevant qualification
- Additional European Language is an advantage but not essential
- May be required to travel overseas on a regular basis
Quality Systems Requirements
- Maintain an understanding of EUSA Pharma working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation