Experience

• 

  Nhs grampian

  Sept 2013 - Jan 2019

  Clinical trial support staff

  • Clinical Trial Databases: - Created and maintained clinical trial databases. - Ensured accurate and up-to-date data entry.Trial Management Files and Systems: - Developed, updated, and tracked study-specific trial management files, tools, and systems. - Ensured compliance with protocols and Standard Operating Procedures (SOPs).Recruitment Data Analysis and Reporting: - Analysed team recruitment data. - Prepared and presented reports to stakeholders.In-House Trial Management: - Managed Trial Management Files and Case Report Forms (both paper and electronic forms). - Ensured data clarification and resolved queries promptly.Study Supplies and Shipments: - Oversaw the management of study supplies. - Coordinated shipments as needed.Liaison and Communication: - Acted as a bridge between medical staff and the research group. - Facilitated effective communication and collaboration.Document Archiving: - Ensured proper archiving of trial documents.Ad Hoc Project Support: - Provided support for various projects following SOPs. Show less

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  University of aberdeen

  Apr 2019 - now

  - Assisting in the overall day-to-day management of multicentre clinical trials - Acting as a point of contact for external and internal inquiries. - Efficiently managing the trials using available Clinical Trial management systems (eConsent, ePRO, eTMF, etc.). - Liaising with the host institution, sponsors, regulatory bodies, and other relevant institutions. - Overseeing study start-up and monitoring recruitment. - Ensuring compliance with research and clinical governance guidelines, data protection, and ethical requirements. - Maintaining quality assurance by documenting procedures and ensuring adherence to trial protocols and Standard Operating Procedures. - Training and supporting trial personnel, including developing training materials, delivering sessions, and responding to queries. - Ensuring timely recruitment of participants and efficient data collection. - Monitoring trial progress to comply with the project plan. - Providing regular information to trial participants and collaborators through reports, updates, guidance, and newsletters. - Handling pharmacovigilance by reviewing and querying discrepant SAE information and MedDRA coding of SAEs. - Assisting with onboarding of new staff. - Providing cover for other study staff when required. Show less • Management of single-centre Randomized Clinical Trials: - Meeting and assessing potential participants for eligibility, addressing their queries. - Creating and managing Trial Databases (inputting, updating, validation, and sharing of Trial Data). - Developing essential study documents (Protocols, Trial Master File, Case Report Forms, Participant Information Sheet, Consent Forms, SOPs, etc.). - Reporting Adverse Events and Protocol breaches to the Sponsors. - Setting and maintaining Trial Timeline Targets. - Conducting other Trial-related tasks according to the protocol.Adaptability and Quick Response: - Spearheaded the transition from Face-to-face Trial visits to Remote Trial visits during the COVID-19 Pandemic, ensuring no disruption to Trial timelines and no missing data.Effective Communication and Relationship Building: - Establishing strong work relationships with Trial participants, Investigators, suppliers, and Trial Monitors. - Resulted in high participant retention/completion rates and meeting appropriate timelines.Budget Monitoring: - Actively involved in monitoring the trial budget.Data Preparation and Reporting: - Coordinating and contributing to data preparation, submission, publication, and dissemination of result - Providing feedback and status updates to sponsors, Trial Steering Committee, and Data Monitoring Committee.Data Analysis and Visualization: - Manipulating and analysing data before presenting it visually to stakeholders.Additional Contributions: - Undertaking other activities related to the Research group, including student training/supervision and Biochemical Assays. Show less

  • Clinical Trial Manager

    Aug 2022 - now

  • Researcher

    Apr 2019 - now