Sr Manager

Responsibilities:

• Partners, collaborates, and develops strong relationships within clinical operations and other functions, to understand the TMF needs to support corporate strategy, corporate objectives, and departmental objectives.
• Provides overall planning for the creation, maintenance and archiving of all Company's TMFs and provides cross-functional oversight throughout the lifecycle of each TMF.
• Monitor technological advances and regulatory evolution and provide an annual analysis of TMF trends and changes and make recommendations to the head of clinical operations systems for any possible changes to the Company's TMF model. Provide a 12-month rolling project plan of TMF work so that internal and external stakeholders are aware of up-coming work and can plan to deliver it.
• Collaborate with Clinical Quality Assurance and Quality Management for alignment on Standard Operating Procedures of TMF processes and periodic audits.
• Provides input into and/or drives the development of TMF operating procedures, work instructions, training materials, and tools.
• Manages the third-party vendor to deliver the necessary support for the Company's sponsored trials i.e. project management, TMF Study Owners, TMF Specialists/QC reviewers, and migration/archive specialists.
• Partner with the Company's CROs to ensure that systems requirements for each trial are set up and delivered per timelines, quality, and budget, and that the end-of-study integration between the CRO and the Company's TMFs are achieved and that the amalgamated TMF is archived with the third-party vendor.
• Manage and lead TMF-related projects to ensure smooth system delivery and sound project management practices.
• Maintain effective communication with clinical study teams, CRO staff and TMF vendor personnel throughout study start-up, maintenance and close out.
• Work with audit inspection readiness teams, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on study TMF compliance and completeness.
• Ensure TMF completeness and inspection readiness by partnering with study teams and performing regular visual document quality reviews and data analysis; conduct quality and completeness reviews to facilitate remediation and mitigation efforts to comply with the company SOP's and regulations.

Qualifications

• 7 years pharmaceutical industry or CRO experience with at least 4 years in trial management
• Minimum of 4 years of exposure to using TMF on multiple domestic and international trials
• Bachelor's degree, with preference in physical, life sciences or computer sciences.