Lara Noble

Managed DMC documentation filing and reconciliation tracking within Veeva Vault TMF for two Rett studies. Assisted the Vendor Management Team in tracking meeting actions and created/managed vendor access trackers, ensuring data accuracy through quality checks. Supported TMF roadmap development, updated EDLs, and resolved quality findings by tracking issues with the CRO vendor.

Supported Clinical Project Managers with study start-up, maintenance, and closure activities for a Dermatology trial. Communicated with clinical sites to obtain study status, request pending documents, and resolve quality issues, uploading documents to Veeva Vault. Maintained tracking systems for document status and key dates, and assisted with clinical data mining and reconciliation.

Managed global and regional oncology clinical trials, overseeing TMF documentation, training matrices, and CTMS maintenance. Facilitated study team meetings, drafted minutes, and ensured compliance with training requirements. Provided eTMF oversight, managed vendor access reviews, and supported site document management and quality control processes.

Supported Phase III and IV oncology clinical trials, managing essential document collection, review, and TMF maintenance in compliance with ICH/GCP guidelines. Provided technical and administrative support for contract tracking, liaising with internal and external partners. Coordinated global study communications, maintained operational tracking systems, and supported audits and inspections.

Supported the Quality Assurance team, managing contract and project tracking for internal and external vendors. Maintained GMP supplier management records, updated quality agreements, and provided support for department metrics and regulatory inspections. Managed special projects, including FDA visit preparations, and handled complex calendar and meeting logistics.

Obtained a Bachelor's Degree in Business Communications. This program provided a strong foundation in communication strategies relevant to business environments.

Completed an Associate degree in Business Administration. This coursework focused on fundamental business principles and administrative practices.