Lakken Wall

• Financial acumen: Manage financial aspects of a project, including budgeting, resource allocation, profitability, invoice review and approval.
• Risk Management: Proactively identify potential risks, analyze impact, develop mitigation and response plans, effectively communicate risks to stakeholders, and monitor throughout project lifecycle.
• Establishing and maintaining the project timeline, ensuring adherence to key milestones and deadlines.
• Facilitate communication and structured process to the team for identifying and addressing critical issues that require immediate attention from higher levels within the team or organization.
• Develop and execute comprehensive risk management strategies, leveraging predictive analytics to mitigate potential project disruptions and gaps.
• Client Audit: Proactively gather all necessary documentation, defining the audit scope and objectives, assigning roles within the audit team, and organizing information to ensure readiness.
• Organize and analyze findings to support the effective management of Corrective and Preventive Actions (CAPA).
• Scope Management: Monitor project activities to identify any out-of-scope work and escalate appropriately for resolution. Submit Financial exemptions and create change order forms.
• Coordinate cross-functional teams utilizing advanced collaboration and communication tools to ensure the successful delivery of complex projects within scope, timelines, and budgetary constraints.
• Stakeholder Presentations: Led or supported internal and client-facing meetings, including the preparation and distribution of slide presentations, meeting minutes, and action items.
• Vendor Management Support: Oversee the management of Investigational Product relabeling, ensuring compliance and timely execution.
• Document Management: Ensure the collection of required documents according to the Trial Master Index, manage timely uploading to the Trial Master File (TMF), conduct TMF reviews, and resolve any quality TMF-related issues through system access.
• Assist in enforcing the redaction of subject-sensitive information and blinded information to ensure compliance with privacy and confidentiality requirements.
• Ensure the project team's adherence to organizational policies, Standard Operating Procedures (SOPs), ICH-GCP guidelines, regulatory standards, and project-specific requirements.
• Monitor and address Data Management and Quality Assurance queries to ensure timely and accurate resolution.
• Foster positive relationships with clients by maintaining open and consistent communication. Proactively addressing and escalating issues to ensure timely resolution and optimal deliverable achievement.

• Organized and implemented study start-up documents, including 1572 forms, informed consent forms (ICFs), protocols, investigator brochures, patient-facing documents, lab and pharmacy manuals, feasibility assessments, subject recruitment procedures, and Delegation of Authority (DOA) forms.
• Ensured clinical trial conduct adhered to regulatory requirements and Good Clinical Practice (GCP) standards, while developing and maintaining source documents in alignment with study protocols.
• Coordinated and facilitated site selection visits, site initiation visits, and monitoring visits to ensure effective study implementation.
• Fostered positive relationships with patients through effective communication and the provision of educational support.
• Completed documentation for Serious Adverse Events (SAEs) and Adverse Events (AEs), developed internal budgets, and managed study start-up and close-out processes, along with study builds.
• Collected, processed, and shipped laboratory samples in compliance with the study protocol.
• Reviewed patient records, databases, and physician referrals to identify potential candidates for research studies.
• Administered investigational products safely and in accordance with the study protocol.
• Documented, assessed, and recorded information accurately and in a timely manner.
• Effectively collaborated with diverse multidisciplinary teams to ensure the execution of safe and compliant study procedures.
• Demonstrated strong organizational skills by developing and updating documents in ShareDrive and hosting weekly meetings with the study team to ensure task completion and adherence to deadlines.
• Collaborated with the principal investigator and sponsors to facilitate daily trial activities, ensuring adherence to research protocols and compliance with study requirements.
• Prepare and manage internal study budgets for clinical trials, ensuring alignment with project requirements and financial constraints.
• Provide support for the Velos build, ensuring accurate setup and configuration in accordance with study requirements.
• Served as the primary point of contact for the CRO and/or sponsor, ensuring effective communication and coordination throughout the project.
• Performed daily EDC data entry and resolved queries promptly to ensure accurate and timely data management.
• Provided comprehensive education to patients on all aspects of clinical study participation, ensuring informed decision-making.
• Collected data in accordance with research protocols, operational manuals, and case report form requirements to ensure compliance and accuracy.

Notable Accomplishments:

• In collaboration with a colleague, I proactively led an initiative to facilitate monoclonal antibody treatments for COVID-19 patients under the Emergency Use Authorization (EUA) in the US. We developed a standardized screening tool within our electronic medical record system, streamlining the process to accommodate the high volume of cases across the three states we served. Additionally, we assumed responsibility for identifying eligible patients and proactively contacting them to inform them of their eligibility for treatment. Over the course of the four-month project, we successfully identified and treated more than 1,600 patients who may not have otherwise received the necessary care.

• Successfully coordinated and facilitated various surgeries through effective collaboration with surgeons and the healthcare team.
• Effectively assessed patient care needs, ensuring smooth patient flow, maintaining high satisfaction, and prioritizing treatments based on urgency and clinical requirements.
• Accurately documented and updated patients' health records in a timely and detailed manner, ensuring comprehensive and up-to-date information.
• Effectively collected subjective and objective data through patient interactions, using this information to assess and develop a focused plan based on the patient's immediate needs and conditions.
• Exhibited strong leadership by representing the Senate and UBC, and consistently prepared and shared monthly reports with the unit to ensure clear communication and updates.
• Effectively educated patients on various procedural topics by providing relevant and appropriate resources to support their understanding and decision-making.