Felix Okinyi

Leading the TMF standards & processes at Biogen, my role involves leveraging best practices, collaborating with stakeholders, and driving compliance through continuous improvement and data-driven insights.

The Manager, eTMF will implement the vision and direction of the eTMF application and associated business processes within Business Process & Solutions (BP&S) department as formulated by the Director/Executive Director. The Manager, eTMF will provide direction, leadership and training to ensure effective and efficient operations. Resolving conflict.

Ensured all eTMF documentation remained consistent with TMF specifications while complying with applicable SOPs. Maintained and promoted continual improvement mind-set to achieve high number of process improvements targeted to enhance compliance and control. • Supervised a team of 21 number of records management professionals, achieving a substantial reduction in errors and a 7% increase in productivity. Initiated cross-training and mentorship initiatives. • Maintained a 99.9% accuracy rate in document categorization and filing over a span of 12 months. • Converted 2 paper TMF studies to a wingspan (electronic TMF). • Managed and archived 16 number of studies, achieving an increase in efficiency from the previous years.

• Lead TMF management activities ensuring timely updates, and provide specialized training on QuintilesIMS systems including Veeva Vault, Wingspan, and PhlexEview, tailored for both sponsors and CROs. • Oversee eTMF periodic reviews, ensuring accurate and efficient processing of all documents in adherence to Clinical File Room procedures. Implement and maintain QC worksheets and tracking logs for hard copy/original documents, ensuring minimal duplication and errors. • Served as the team leader for records management projects, ensuring timely completion, coordinating record retrieval, and preparing closed studies for client transfer. Guide and mentor staff on TMF processes, boosting team efficiency and productivity. • Assist in implementing strategic goals, resource projections, and cost proposals. Oversee the transfer, recall, and disposition of records, optimizing storage space, supplies, and equipment utilization.

• Filing of the TMF documents into the TMF (both paper & electronic documents). Ensured less than 10% error rate for each filing and rejection from clinical teams. • Mastered the use of Veeva Vault, Wingspan, and PhlexEview, tailored for both sponsors and CROs. • Ensured accurate and efficient processing of all documents in adherence to Clinical File Room procedures. • Maintained QC worksheets and tracking logs for hard copy/original documents, ensuring minimal duplication and errors. • Prepared closed studies for client transfer. With the guidance of the manager TMF • Provide consultative services on Records Management processes to both Sponsors and internal customers

Ability to use EMR (care360 and MD), Syntactx (DNA-DATA patient entry), and UPGRADE Coordinate study of the clinic under the InvestigatorDocument adverse events; Prepare or review documents submitted to the institutional review board (IRB); Protocol review or study procedures planning;Participate in conducting subject visits; Maintain source documents; Prepare for and participate in study visits with monitor, sponsor, auditors, etc.; Participate in consent process

▪          Participated in protocol development, preparation of IRB and CTRC applications and research project materials with PI and other investigators ▪          Planned, coordinate, and monitor several satellite study sites, ensuring enrollment and protocol compliance and regulatory documents are filed and current. ▪          Planned, organize and coordinate project implementation ensuring all compliance is current and filed appropriately ▪          Creating systems of organizing documents and storing them in repositories for efficient access; teamwork; and collaborating across organizational lines to achieve institutional goals.

Technician I- Intern- Gentris Corporation 16 Aug 12 - 21 Dec 12 ▪         Assesses daily accessioning activities and work prioritization as well as communication with study directors. ▪         Accessions client samples using approved standard operating procedures. ▪         Assists in sample receipt and verification of client samples.

Relevant Clinical Trials Knowledge: Clinical research processes and drug development, federal regulations, GCP and ICH guidelines, IRB submissions, site regulatory documents, CRFs, queries, data management, auditing, SOPs, Pharmacovigilance, research terminology, informed consent, pharmacology, pathophysiology, respiratory care & therapeutics, patient management, monitoring visits and site preparation, collecting study data, AE and IND safety reporting, scientific development of research protocols and their key elements.