Dr. Norma Lyn

Clinical Trial Risk Manager: Lead the successful implementation and ongoing execution of Risk Management for assigned, global clinical studies, across early and late phase and observational clinical research.

Coordinate and oversee the execution of risk management for GCPM managed studies, (early, late and observational), globally.

Oversee the quality of risk management for studies at a global level. Collaborates with cross functional stakeholders to ensure continuous, timely and quality risk management.

Ensuring risk management implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines.

Accountable for CT-RACT completion and updates (performed by the Clinical Study Team) throughout the lifecycle of the clinical study.

Input to the development of the study protocol and functional plans.

Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes.

Guide team on the process, requirements and how to complete the CT-RACT.

Review and ensure holistic quality (e.g. risk grading has sufficient rationale, not responsible to ensure inclusion of the appropriate study risks).

Responsible for feedback on risks to protocol development.

Support the development of risk mitigation strategies.

Provide advice on the development of functional plans.

Support messaging, training and roll out of tool enhancements.

Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.

Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.

Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.

Conducted risk identification and contingency planning.

Mentor, onboard, training and management of Clinical and Startup Team.

Analyzed study financial statements and contractual agreements.

Administered site activation activities and managed scope of work against timelines, costs, and quality.

Provided clear direction to internal teams, setting expectations and due dates for deliverables.

Coordinated team members to ensure tasks were completed on time and within budget.

Documented project requirements, processes, and procedures.

Identified potential risks and developed strategies for mitigating them.

Led meetings to detail project milestones, brainstorm ideas and determine appropriate techniques to manage tasks.Developed and maintained project plans for multiple studies, tracking timelines, milestones, deliverables and resources.

Successfully managed multi-million global research projects in NA, EMEA, APAC, and LATAM from start-up to closeout, encompassing phases I-III.

Impressive track record of achieving a remarkable 60 percent reduction in timelines and significantly lowering study costs.

Led proactive trial management and developed mitigation plans.

Identified new clinical site relationships and maintained contact database.

Managed clinical trials from site identification to closeout.

Consulted with internal and external partners for successful protocol implementation.

Oversaw hiring and training of study staff and mentored/train CRAs.

Led proactive trial management and developed mitigation plans.

Identified new clinical site relationships and maintained contact database.

Managed clinical trials from site identification to closeout.

Consulted with internal and external partners for successful protocol implementation.

Oversaw hiring and training of study staff and mentored/train CRAs.

Pfizer Trials record breaking timelines for activation.

Accountable for program deliverables and client relationship.

Managed project milestones and allocated tasks for timely delivery.

Conducted feasibility questionnaires for new studies.

Led recruitment strategies and exceeded enrollment goals.

Oversaw clinical trial safety, efficacy, and documentation.

Directed a multi-million dollar research facility focused on women's health. Top enrolling site in the US for Abbvie Endometriosis and PCOS studies.

Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs and study team as protocol expert.

Reviews Monitoring Visits Reports and escalates performance issues.

Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Established a network of oncology practices in Central Florida working with over 100 oncology sponsors.

Monitored protocol and regulatory compliance for research studies.

Examined and reported accuracy of research data.

Traveled to monitor collaborating sites and trained other Monitors.

Conducted physical exams, histories, and adjustments

Created care plans and assessed patients' overall health.

Provided chiropractic treatment and outreach services.

Review, interpret and report patient results as assigned.

Perform, review and document laboratory quality control procedures.

Perform and document reagent qualifications per the approved protocols.

Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

Perform and document routine preventive maintenance.

Assist with training of new laboratory personnel and training of new procedures with existing personnel.

Write and revise standard operating procedures, as needed.

Participate and comply with Quality and applicable regulatory requirements.

Conduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFS, source documents, medical records, and regulatory documents.

Determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements.

Assist in assessing the suitability of potential investigative sites through telephone screening interviews, regulatory document review

and disseminating clinical trial information.

At the UCF college of Nursing, developing and execution of clinical trials in psychiatry, gen/med, rare diseases, hematology and oncology trials.

Devised plans and schedules for concurrent projects to meet established deadlines.

Provided clear direction to internal teams, setting expectations and due dates for deliverables.