Responsible to lead Faron’s clinical operations, scientific & supply teams of 8-9 personnel, through the end-to-end development cycle of clinical programs. This role holds key responsibility and accountability to provide tactical leadership in overseeing, designing and execution of clinical activities, to achieve the strategic direction, objectives, and key milestones for the business.• Responsible for the line management of the clinical operations and clinical supply functions• Accountable for overall management of clinical trials including study deliverables, milestones, data quality and engagement and management oversight of CROs and further relevant study vendors • Responsible for establishing and managing budgets for clinical activities• Act as a key contributor to the development, review and approval of study documents including protocol, ICF, statistical analysis plan, and clinical study reporting.• Implement and drive operational excellence and continuous improvement in process standards/tools and establish best practices in clinical trial management • Assure compliance with all regulatory requirements associated with clinical research and drive data collection, clinical trial database construction, data audits and database queries to verify data accuracy and manage contracting with research collaborators/investigational sites.• Ensures alignment and information flow among team members and all stakeholders; drive coordination of cross-functional activities, and facilitates the execution of agreed upon clinical goals.• Develop & oversee the clinical risk management process at Faron, including process reviews (as required) focusing on the implementation of effective Quality Tolerance Limits across Faron’s clinical programs• Design, implement and oversee project management tools including, but not limited to: RACI tools, KPIs, project management software, GANTT charts

Responsible for leading program(s) through the end-to-end clinical development cycle to seek successful registration and market access. This position will drive optimal life cycle management of approved assets, and have overall accountability for quality, time, cost, proactive risk management, and compliance.- Overall leadership and accountability for the operational components of Faron's clinical programs- Facilitates, oversees and contributes to clinical development strategy formation- Manages and tracks Faron's Clinical Development Plans including integrated timeline, deliverables, and metrics- Strategise, plan, and contribute towards regulatory body interactions (e.g. FDA meetings) and designation applications- Strategise improvements to patient recruitment, engagement and diversity across the clinical programs- Ensures alignment and information flow among team members and all stakeholders; drive coordination of cross-functional activities, and facilitates the execution of program goals- Develop & oversee the clinical risk management process at Faron, including process reviews (as required) focusing on the implementation of effective Quality Tolerance Limits across Faron’s clinical programs- Design, implement and oversee project management tools including, but not limited to: RACI tools, KPIs, project management software, GANTT charts- Build and maintain strong relationships with internal and external service providers to ensure operational excellence across Faron’s clinical programs- Act as a practitioner of continuous improvement, striving to identify key areas of improvement and work with internal teams to best improve Faron’s processes

Responsible for the oversight of the overall clinical supply chain and non-clinical operations of the Traumakine and Bexmarilimab products.-Serving as point of contact and responsible person for any related vendors-To ensure seamless provision of drug and ancillary supplies-Managing labelling, packaging, distribution and system activities, including review and approval of different GxP records-Clinical supplies forecasting and planning-Management of IRT systems for drug supply demands-Temperature deviation management of clinical supplies-Creation of clinical site pharmacy manuals-Preparing, reviewing and formatting support documents for clinical trials-Collating documentation for the clinical TMF-Strategising and planning commercialisation-Patient sample management, oversight and logistics-Develop and analyse full spectrum performance metrics to drive efficiency and improvements-Develop plans and strategies for commercialisation of Faron's products, leading the project of potential expansions-Design, launch, train and oversee a Project Management tool to be used on all projects-Design, launch, train and oversee a RACI and KPI tool to be used on all projects

Responsible for the management and development of a Project Management team (of 7) within the Clinical Trial Supply & Commercial Services.- Accountable for the management of projects through award, set up, planning, monitoring and execution.- Participation in the development of proposals and bid defences to support business development and the award of work to the Catalent network.- Focus on Customer Service Excellence when working with all internal and external clients, promoting this thought process to ensure the Project Management team adopt the same approach.- Acting as point of escalation and expertise on my team's clinical and commercial manufacture/development projects.- Accountable for team compliance with SOPs, financial forecasting, revenue generation and new technology adherence.- Authoring and reviewing standard operating procedures to support best practice in the project management.- Deputising for the Director of Project Management and supporting their role as a senior member of the site.

Project Management of Clinical projects within Catalent's Clinical Trial Supply & Development Services.Project manage the outsourced clinical manufacture, supply chain & operations of a molecule from pre-clinical phase, through to commercialisation.Assist in clinical trial study setup with a wide variety of pharmaceutical company clientele.Monitoring, reconciling and reporting inventory stock levels to ensure constant supplies available for clinical supply.Coordination of multi-disciplinary teams (QA, production, regulatory, etc) to ensure the overall success of projects. Work with Sales to support the winning of new businesses and continuous liaison with Sales in terms of additional scope of work, and future contracts. Establish full project plans, including timeline, critical path assessment, risk assessment, contingency planning, mitigation planning, and confirm scope capture during planning phase of a project. Communicate project progress to the client and the project team on a regular basis (by status reports, meetings and teleconference).Full budget tracking: experience in managing projects worth millions of USD and other trials with tight, small budgets.Preparation and regular review of Standard Operating Procedures.Subject matter expert (superuser) in Enterprise Resource Planning system ‘JDEdwards’ – performing regular training to teams to ensure efficient use of the system.Involved in global implementation of new ERP system throughout the Catalent clinical network.Part of the core team on the key Catalent 'follow the molecule' initiative. Guiding molecules from pre-clinical through to commercialisation, optimising cross-functional project management.Matrix line management and mentoring of junior members of staff; performing training and developing soft-skills.Undertook formal Project Management 'Systemation' training (recognised by PMI)Undertaking formal line management training (certified by CMI)

Assist project managers with the development of clinical documentation. Interact closely with production, quality assurance, and other departments to execute project requirements and gather paperwork needed for drug records in order for the project completion. In addition it has been my responsibility to assist the coordination of the whole project from client to dispatch.Creation of GxP compliant records built on project source documentation obtained from collaboration with the project management and client. Understanding client and patient’s individual needs and aid in the design of personalised clinical trial solutions.Plan manufacture orders around production capacity, liaising with planning directors.

Working closely with the pharmacy manager, training man management and teamwork skills. Giving advice on ailments and appropriate medicines and learning a variety of appropriate health and safety procedures with medicines and drugs. The job role came with a requirement to learn a large database of medications for recommendation to patients. Taking, making-up and giving out prescriptions; maintaining a high level of attention to detail.Professional contact with GP surgeries and patients concerning their medication and deliveries. Including crisis phonecalls when patients were unhappy with the service provided.Management of prescriptions and stock levels using a SAP system.Training colleagues in the use of SAP.