Danielle Grindley

• Drive the adoption and continuous improvement of RBQM practices across complex clinical trial portfolios.
• Complete and monitor protocol risk assessments across multiple domains (clinical, operational, data management, vendor management, regulatory) to identify critical-to-quality (CtQ) data and processes.
• Define, implement, and monitor Quality Tolerance Limits (QTLs) and risk indicators to proactively manage trial risks.
• Draft, maintain, and archive Integrated Quality Risk Management Plans (IQRMP) to ensure robust documentation of risk management activities.
• Collaborate with system configuration teams to align analytics, visualizations, and dashboards with operational requirements.
• Conduct ongoing central risk surveillance using Cluepoints and in house analytics software to detect emerging risks and ensure timely mitigation.
• Lead risk review meetings with study and program teams to communicate findings, support root cause analysis, and develop mitigation strategies.
• Support audits and health authority inspections, ensuring compliance with ICH, FDA, and GCP guidelines.
• Collaborate with training teams to promote RBQM methodology adoption, deliver training, and champion best practices across teams.
• Identify and share lessons learned, driving continuous process improvement and fostering a culture of knowledge sharing and innovation.
• Serve as subject matter expert and change agent for RBQM, providing guidance and mentorship to junior team members as needed.

My responsibilities include:

• Communicate effectively with cross-functional teams regarding project deliverables and advise on data science and digital health solutions for data collection, analysis, and interpretation.
• Define and generate key study metrics and/or risk-based reports and visualisations for periodic review, including QC and monitor for anomalies.
• Provide input into the evaluation and selection and/or generation of data collection tools and platforms to support the use of medical grade devices, sensors (‘big data') and decentralised trials.
• Support the development of solutions for data collection, metrics, and risk-based monitoring, including KRIs, through visualisation, analytical, machine learning, and artificial intelligence techniques.
• Conducted risk assessments, supported RBQM initiatives, and collaborated with data analytics teams.

My responsibilities included:

• Supported RBQM initiatives, and collaborated with data analytics teams.
• Assisted with sponsor audits, inspections, and implementation of CAPAs.
• Engaged cross-functional stakeholders to resolve operational issues and optimize study performance.

• Contribute towards the creation and management of SOP's, DMP's and associated documentation.

• Provide assistance on RWD protocols and work with internal departments to ensure ethical approval is obtained.

• Work with internal and external stakeholders on data collection elements and provide support for bid defences, platform demonstrations and work orders.

• Manage RWD management activities during set up, conduct, and close out of projects.

• Ensure the uninterrupted collection, validation, and reporting of real-world data to agreed regulatory or publication standards.

My responsibilities included:

• The design, validation, and testing of eCRF/CRF's with liaison from the trial team for new trials.
• Set up and maintain the Data Management Plan (DMP) alongside all the record management systems required for the trial, including sample collection and patient data alongside the trial team.
• Assist the trial team in drafting reports or presentations and take minutes for meetings as required.
• Responsible for all aspects of data review and cleaning, from designing, building, testing, and running of data checks on the JReview software. Alongside raising, answering, and chasing outstanding data queries.
• Responsible for tracking eCRF compliance and any outstanding samples from the participating sites to the trial unit/central labs to ensure the trial data/samples are received at the correct time points.
• Answer any telephone queries and, when necessary, conduct trial-specific data management training for the participating sites.
• Responsible for documenting and completing database change requests.

My responsibilities included:

• Complete both paper and electronic CRF's in a timely and accurate manner.
• Responsible for answering any queries on all aspects of CRF completion with both members of the research team and the sponsors.
• Reviewing medical records to collect the required data quickly and ensuring source data is available when required
• Disseminate and write up notes from office meetings.