• Collaborate with assigned team to successfully meet client deliverables for complex projects and serve as the primary point of contact, providing guidance and support.• Manage and nurture relationships with Strategic clients, driving customer success, retention, and loyalty while growing existing client relationships through exceptional service and innovative technology solutions.• Coordinate with the project team to educate and advise clients on optimal approaches, investigating and resolving client complaints to prevent recurrence and implementing systemic changes.• Communicate critical information to senior management promptly, consult effectively with essential project workflow departments, and ensure compliance through filing reports and collaborating with Quality Assurance.• Provide training, mentorship, and support to new employees, ensuring their professional development, oversee study budgets, maintaining strict adherence to deadlines, budgets, and high-quality results.

• Conducted quality review of TMF, ensuring both quality and completeness of documents, while successfully managing the transfer of two critical studies from CRO's eTMF to Agios' eTMF. Led TMF Index mapping, tracked transfers, and completed quality review with limited staffing resources, collaborating with CRO, system Vendor, and Internal Study Team for timely query resolution in preparation for FDA Inspection.• Managed outsourced TMF resources and provided valuable suggestions and recommendations to Study Teams and CROs, collaborating on job aid and training material development.• Assisted in training new employees, reviewed/upgraded TMF Index Template and TMF Configuration Manual, and identified process improvement opportunities.• Created cross-study tracker to identify document filing trends, gaps, and inconsistencies, and actively participated in evaluating eTMF system functionality and UAT for new features.• Reviewed User Access Requests, assisted Study Teams in final document review, addressed Audit Findings, and maintained eTMF study room inventory.

• Collaborated with Business Development and Product Development teams to assess project scope, generate accurate cost estimates, cultivate client relationships, and drive lead development through initiative-taking service and technology-driven approaches.• Ensured meticulous adherence to deadlines, budgets, and high-quality results, adapting project plans to accommodate evolving targets, staffing changes, and operational requirements.• Exercised tactical control over project budgets and timelines, fostering team focus, enhancing customer satisfaction by 90%, and maintaining stringent budget control for Technical and Services projects.• Analyzed problems, optimized resource allocation, and implemented actionable solutions to drive efficiency.• Led highly productive teams, defining targets, developing work plans, and consistently completing projects ahead of schedule.• Monitored contracts and service level agreements, proactively mitigating potential risks.• Orchestrated projects within tight time frames and budget constraints, leveraging critical thinking skills and collaborating closely with senior leadership.

• Provided global oversight of Trial Master File (TMF) integrity, defining and implementing processes for robust compliance.• Aggregated and analyzed data, delivering meaningful reports to support informed decision-making.• Led global training sessions on critical tools and processes for key TMF milestones.• Offered guidance on TMF content and processes to ensure consistency and compliance.• Successfully managed the global hand-off of electronic TMF Substance regulatory documents.• Conducted analysis of regulatory documents for accuracy and completeness.• Represented the team in pilot programs, contributing to successful system and process rollouts.• Monitored regulatory activity to ensure compliance with document management laws.• Assisted in implementing electronic document processing systems, providing support documentation and training materials.• Proficient in the DIA Reference Model, utilizing industry best practices for effective TMF management.• Managed project progress, assessing risks and coordinating contingency plans.• Facilitated effective team communications and liaison department meetings.• Monitored and generated control reporting to track system integrity, vendor performance, and internal workflows.• Assessed the impact of emerging technologies and upgrades on workflow efficiency.

• Spearheaded testing, training, troubleshooting, and management of database systems and portals, ensuring smooth operations.• Enhanced caller satisfaction by 90% through bilingual call center flow mapping and Spanish phone menu options.• Designed and maintained comprehensive departmental SOPs and scripts for streamlined operations.• Identified and reported Adverse Drug Events, prioritizing compliance and patient safety.

Documented and archived original clinical trial manuals using electronic records management system to be used with trial reports and regulatory submissions. Designed new electronic index in CRF Track database for new clinical trials; used imaging software to produce and maintain virtual documents of case reports forms and data clarification forms