Responsible for the day-to-day management of the TMF, including the review and approval of TMF documents and generation of reports to measure completeness, accuracy, and timeliness of the TMF. • Performed quality review of documents submitted for TMF filing. Ensures clinical trial documentation is consistent with ICH-GCP guidelines, regulatory requirements, and applicable SOPs. • Filed documents in the eTMF per the TMF Index and Plan, applied relevant metadata. • Identified quality issues on TMF documentation, working alongside cross functional teams for timely resolution. • Conducted cross-check and co-dependency checks on TMF documentation to aid in proper filing and identify missing documents. • Ran system reports to assess TMF health, including interpretation, delivery, and follow-up with stakeholders. • Maintained up to date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements. • Assisted with inspection/audit related activities (e.g., preparation, corrective action plans). Contributes to process improvement activities.

Processed study documentation following Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines, and study-specific TMF Plans. Supported the set-up, maintenance, and closure of TMF repositories. Supported documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF. Document filing for trials using a paper TMF. Participated in study-specific training as required.

Supported project meeting preparation, execution, and collection/distribution of materials.Provided administrative support to project management and assigned projects.Archived study documentation based on established policies and guidelines.Engaged in quality reviews as part of audit preparation to ensure completeness of study documents.Maintained study information on a variety of databases and systems.Prepared and coordinated with internal study team members to develop study deliverables.Monitored study deliverables.Facilitated access requests for study team members and site personnel across multiple study databases.Generated TMF completeness reports and identified missing site-level documents for close-out visits. Collaborated with TMF Lead to assign TMF queries to appropriate document owner.

Assisted in developing draft Investigator Study Agreements (ISA) consistent with inVentiv Health Clinical and client expectations. Participated in developing investigator grant budgets and supporting documents according to protocol specifications. Negotiated contractual terms and clinical study budget with investigators or designated site personnel. Prepared budget and contract amendments driven by study protocol amendment and protocol addenda.

Developed clinical trial agreement templates and payment schedules based on protocol. Established acceptable template language, change parameters, and budget limitations with sponsor at the onset of the study.Reviewed clinical site proposed revisions to the agreements and facilitated resolution to business issues outside of established parameters with appropriate decision makers.Provided regular reports on the status of agreements to operational staff and clients as needed to satisfy reporting obligations.Worked with the project teams to prioritize completion of the agreements and budgets to ensure timely site activation.Participated in both internal and external project team meeting to provide concise, current project status updates.Tracked progress of deliverables in tracking tool and distributed to the project team.

Prepared and negotiated investigator contracts.Collaborated with the Associate Director in preparing contract documents for distribution and follow-up.Negotiated investigator contracts with SMOs, private sites and institutions. Prepared and assisted in the preparation of investigator budgets (grants)