Nancy Macdonald Email & Phone Number

Cambridge, England, United Kingdom

 Working in close collaboration with the CPM to coordinate the set-up, maintenance, and close out of assigned clinical trials and programs, conducted by GW and/or CRO clinical project teams. Trial Master File (TMF) set-up/management/oversight. Contributing TMF/eTMF expertise across project teams Supervision of department members; processing improvement and training. Ensuring compliance with applicable international and local regulations/standards and GW SOPs. Maintaining… Show more  Working in close collaboration with the CPM to coordinate the set-up, maintenance, and close out of assigned clinical trials and programs, conducted by GW and/or CRO clinical project teams. Trial Master File (TMF) set-up/management/oversight. Contributing TMF/eTMF expertise across project teams Supervision of department members; processing improvement and training. Ensuring compliance with applicable international and local regulations/standards and GW SOPs. Maintaining current GCP and Health and Safety knowledge applicable to the job. Contributing to development of trial coordination business processes in development of partnership arrangements with CROs. Leading alignment of processes/activities for multiple trials within a development programme, or placed with the same CRO. Deputising for CPM as primary GW contact (as delegated), or in CPM absence. Contributing to, maintaining and distributing project plans, essential documents and other project documentation. Creating and distributing metrics reports as required to internal and external stakeholders. Monitoring trial metrics for compliance with project plans, quality standards and procedures.  Proactively identifying potential trial issues/risks and recommends/implements solutions, ensuring appropriate consultation/escalation. Coordinating trial risk management plan. Attending project meetings and reporting on trial progress as required. Assisting with reviewing/writing meeting minutes.  Coordinating provision of trial materials, equipment and supplies to CRO/sites (e.g. syringes, drug accountability tools, ECG machines). Aspiring to inspection readiness at all times; contributing to internal/site audits and regulatory inspections as directed. Show less

Ely, Cambridgeshire, Uk

Interface with Client representatives and SYnteract study team to ensure timely initiation and completion of clinical trials. Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Managing the set up and maintenance of electronic Trial Master Files (TMFs) using Veeva… Show more Interface with Client representatives and SYnteract study team to ensure timely initiation and completion of clinical trials. Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Managing the set up and maintenance of electronic Trial Master Files (TMFs) using Veeva Vault; performing file reviews of the TMF and reconciliationDeveloping/adapting documents such as TMF Plans/Guidelines, SOPs and Work instructions according to study related requirements.Maintaining and updating project-related data in an existing database (CTMS) which involves liaising with internal team members to gather information and resolve queries. This includes preparation of status reports for the study team and client.Sending out safety reports to sites and tracking receipt of these.Assisting in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness.Arranging translations of study documents for global studies.Setting up training database to include uploading training materials and assigning team members to training. Assisting in the planning, organisation and execution of project-specific meetings.Preparing and contributing to study related correspondence, including meeting minutes, tracking spreadsheets and presentations.Responsible for the shipment and tracking of trial materials.Contributing to preparation, support and follow-up of study specific audits.Developing/adapting documents according to study related requirements.Accompanying CRAs on site visits. Show less

Ely, Cambridgeshire, United Kingdom

Interface with Client representatives and SHCR study team to ensure timely initiation and completion of clinical trials. Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Creating Trial Master Files and Investigator Site Files and support in maintaining these for… Show more Interface with Client representatives and SHCR study team to ensure timely initiation and completion of clinical trials. Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Creating Trial Master Files and Investigator Site Files and support in maintaining these for the duration of the study. Maintaining and updating project-related data in an existing database (CTMS) which involves liaising with internal team members to gather information and resolve queries. This includes preparation of status reports for the study team and client.Assisting in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness.Arranging translations of study documents for global studies.Assisting in the planning, organisation and execution of project-specific meetings.Preparing and contributing to study related correspondence, including meeting minutes, tracking spreadsheets and presentations.Responsible for the shipment and tracking of trial materials.Contributing to preparation, support and follow-up of study specific audits.Developing/adapting documents according to study related requirements.Accompanying CRAs on site visits. Show less

Ely

Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Creating Trial Master Files and Investigator Site Files and support in maintaining these for the duration of the study. Maintaining and updating project-related data in an existing database (CTMS) which involves… Show more Assisting with all aspects of trial management in accordance with the ICH-GCP, applicable local regulations and Standard Operating Procedures.Serving as a mentor to junior CTAs by providing guidance, training and direction in project-related tasks and departmental processes.Creating Trial Master Files and Investigator Site Files and support in maintaining these for the duration of the study. Maintaining and updating project-related data in an existing database (CTMS) which involves liaising with internal team members to gather information and resolve queries. This includes preparation of status reports for the study team and client.Assisting in the preparation, receipt, collection, tracking and review of essential documents to confirm completeness.Arranging translations of study documents for global studies.Assisting in the planning, organisation and execution of project-specific meetings.Preparing and contributing to study related correspondence, including meeting minutes, tracking spreadsheets and presentations.Responsible for the shipment and tracking of trial materials.Contributing to preparation, support and follow-up of study specific audits.Developing/adapting documents according to study related requirements.Accompanying CRAs on site visits. Show less

Cambridge, United Kingdom

Filing and tracking study related documentation in TMFs and eTMFs using Sharepoint.Management of clinical document storage facilities (electronic, fire safe and off-site archiving). Nominated archivist for clinical trial documentation.Assisting in submission of clinical trial documentation to the regulatory authorities and ethics committees.Arranging and taking minutes at Product Team meetings.SOP controller for all company SOPs related to Clinical Trials. Assist in compiling… Show more Filing and tracking study related documentation in TMFs and eTMFs using Sharepoint.Management of clinical document storage facilities (electronic, fire safe and off-site archiving). Nominated archivist for clinical trial documentation.Assisting in submission of clinical trial documentation to the regulatory authorities and ethics committees.Arranging and taking minutes at Product Team meetings.SOP controller for all company SOPs related to Clinical Trials. Assist in compiling and reviewing specific SOPs.Control of quality documentation relating to CRO, Site and internal audits.Supportive administrative role for the Clinical Operations Team. Show less

Cambridge, United Kingdom

Responsible for the preparation of start up documentation relating to REC and Trust R&D submissions in line with the European Directive and ICH-GCP. Updating study tracking software for study status reporting.Support in co-ordination of study related meetings – Investigator, site selection and initiation; co-ordination with the site and sponsor company.Supporting the Business Development Manager in the co-ordination of outgoing and incoming feasibility to meet required… Show more Responsible for the preparation of start up documentation relating to REC and Trust R&D submissions in line with the European Directive and ICH-GCP. Updating study tracking software for study status reporting.Support in co-ordination of study related meetings – Investigator, site selection and initiation; co-ordination with the site and sponsor company.Supporting the Business Development Manager in the co-ordination of outgoing and incoming feasibility to meet required timelines.Responsible for study filing and archiving. Show less

Cambridge, United Kingdom

Responsible for general office & clinical trial administration. Generation of clinical trial document templates.Managing a system for tracking clinical trial documentationFiling business and clinical trial documentation.Arranging & organising internal and external meetings.Management of diaries & schedules.Booking flights/transport & hotel accommodation for training courses.Personnel issues such as recruitment, training and arranging honorary contracts.Facilities… Show more Responsible for general office & clinical trial administration. Generation of clinical trial document templates.Managing a system for tracking clinical trial documentationFiling business and clinical trial documentation.Arranging & organising internal and external meetings.Management of diaries & schedules.Booking flights/transport & hotel accommodation for training courses.Personnel issues such as recruitment, training and arranging honorary contracts.Facilities management Show less

Hnd In Travel And Tourism

A-Level French

Education record

Activities and Societies: Choir O-levels French, Maths, History, Music, Geography, English Literature, English Language