Experience

Allergy Therapeutics

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Clinical Compliance and Training Manager

  • Mar 2022 - Present



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Compliance, Process, Training and Systems (CPTS) Advisor

  • Aug 2017 - Feb 2022

  Country Lead for the end-to-end Investigator Initiated Studies, advising on processes, and development of training for operational functions. Provision of expert advice on GCP matters to a department of 120 Country Clinical Operations employees within the UK HQ site. Collaboration with Global Process Owners (GPOs) on GCP quality initiatives within business-critical timeframes, review and influence global processes for successful implementation in the UK. Communication of change at all levels of the business from local stakeholder to global stakeholders to ensure effective planning, implementation and change management of processes. Tactical implementation of Continuous Improvement projects such as ICF development and reconsent, AE reporting. Performing quality checks on clinical trial units, internal and external processes to ensure compliance with GCP and all relevant industry guidance and standards e.g., ICH, EMA, FDA, Root Cause Analysis and CAPA review (Critical Quality Events/Serious Breaches, Audit findings, self-identified GCP deviations, site, and country level GCP issues and supporting clinical site staff and PIs on implementing corrective and preventative actions) Training design and delivery through WebEx and face to face workshops Show less



Richmond Pharmacology

• United Kingdom
• Research Services
• 100 - 200 Employee

• Clinical Operations and Training Manager

  • Sep 2014 - Sep 2017

  Clinical Operations and Training Manager within a CRO that focuses on early phase studies, including TQT, First into Human and bioequivalence studies. My responsibilities include; Developing and updating SOPs in line with the evolution of clinical trials within the company moving towards more patient focused studies. Managing and coordinating the internal quality control team and driving the focus on quality measures to ensure accuracy of data entered into CRFs. Writing and delivering training presentations on informed consent, data recording and quality control of study documents. Establishing new quality control systems and processes to bring in line with current clinical trials. Contributing to process improvements, e.g. establishing an innovative training programme which has led to an improvement in new members of staff obtaining their SOP related qualifications in order to be delegated to work on studies. Responsible for the quality control of study documents, including CRFs and Study Operation Manuals. Managing study specific resource requirements during the course of the study, specifically ensuring adequate numbers of trained staff. Creating a process for the induction of new members of the team into the company, to ensure their quick assimilation into their role. Co-ordination of study specific training for all relevant staff members. Creating training profiles for new staff members and those who move to different job roles internally. Liaising with CRAs and providing them with sufficient training and understanding of the company delegation system. Show less



King's College Hospital NHS Foundation Trust

• United Kingdom
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Nurse

  • Feb 2012 - Sep 2014

  Clinical Trials Coordinator for Haemato-oncology studies. My responsibilities included: Accurate REC/R&D submissions for numerous haemato-oncology studies, both early and late phase. Accountable for overall patient recruitment including contingency planning e.g. opening other hospital sites to improve recruitment. Participating in site selection visits. Tracking study progress against milestones at each stage of the study, including submissions, recruitment, data collection and data management. Participating in monthly feasibility meetings, which entailed reviewing all ongoing and potential studies to maintain an appropriate distribution of trials to ensure all therapy areas were met and ensured accurate costings of all internal studies. Participating and co-ordinating investigator and monitors’ meetings with the study team. Reviewing of clinical study protocols. Ongoing management and reporting of study specific safety issues and SAE reporting. Reviewing and regularly updating all study databases on an ongoing basis. Setting-up, maintaining and ensuring the accuracy of central study files. Developing timelines and milestones for internal studies. Responsible for distribution of Clinical Study Reports to the relevant team members. Co-ordination of the clinical aspect of the trial, including liaising with the clinical team, managing the patients (and their visits), and organising the processing and shipment of laboratory samples. Developing and maintaining a relationship with hospital pharmacy staff, to keep them informed of the ongoing and upcoming treatments and ensuring quality control of study prescription sheets. Induction training for new members to the medical team on clinical trials. Show less



Richmond Pharmacology

• Clinical Quality Manager

  • 2009 - 2012



Frimley Park Hospital NHS Foundation Trust

• United Kingdom
• Hospitals and Health Care
• 700 & Above Employee

• Staff Nurse

  • 2007 - 2009