Danielle L. Email & Phone Number

England, United Kingdom

Outsourced to Jazz Pharmaceuticals

• Introduction of new TMF operations team and process, providing input to improve processes
• Drive inspection readiness activities across global cross functional groups on multiple studies
• Clinical Trial Team member, providing updates and offering TMF expertise at study team meetings
• Mentor new starters and oversight of team members
• Working closely with Global Trial Manager on activities such as protocol deviations, risk management, vendor management and other ad hoc activities- change management lead

- Responsible for being the TMF accountable person ensuring the TMF is always inspection ready.- Leading the global cross functional study team across multiple projects. - Providing project management skills to the global study team to support study deliverable targets - Working closely with CRO’s to agree ways of working at start up and have oversight.

-Ensuring all clinical trial processes follow a core set of activities adhering to GSK processes and SOPs.-Oversight of third party vendors.-Periodically reviewing quality and completeness of the TMF while serving as main POC for study teams and TMF enquiries.-Responsible for globally supporting multiple studies from start up to close out.-Providing.

Slough, United Kingdom

Data Management-Data reconciliation, data validation and data cleaning.-Maintaining data entry issues logs whilst solving issues via CRA.-Updating the database where discrepancies are found.-Assist in preparation of data entry guidelines-UAT and query management.

Slough, United Kingdom

Data Management-Responsible for setting up and performing accurate quality check of data, whilst tracking completion within the database.-Tracking CRF's as received using DataLabs and scanning onto a shared portal and sending acknowledgements to the CRA and data entry team.