• Utilize standard and corporate specific Risk Assessment and Categorization Tools (RACT) to identify critical data and processes, identify study risks, both operational and execution, evaluate risks and propose study specific controls/mitigations to eliminate, avoid, and/or monitor occurrence of issues.• Develop cross functional quality management systems / monitoring strategies proportionate to the risks identified and the criticality of the information collected based on human subject safety risks and objectives of specific study protocols. • Propose and consult as a Subject Matter Expert (SME) with clinical operation teams to implement risk-based monitoring strategies that are rooted in logic, systematic in nature, and focused on study specific risks. Guide clinical study team to document the plans for monitoring source at the investigative site (on-site) and collected data centrally/remotely with contingencies for emerging issues and flexibility based on investigative site performance.• Advise and collaborate to program and configure study specific analytics to surface data, compliance, and safety issues.• Contribute to and drive corporate initiatives and process improvements by analysing current processes and operations, obtaining input from end users, and implementing change management plans to further the implementation of a risk-based approach to trial design and quality management as per ICH E6(R2) and E8(R1) guidelines.• Support Business Development and Proposals by conducting initial risk assessments and proposing project management and clinical operations monitoring strategies based on limited study plan information.

- Pilot and direct the completion of a robust protocol or portfolio risk assessment, which aligns with ICH/GCP E6 (R2) and utilizes a Risk Assessment and Categorization Tool (RACT). - Promote discussions and inspire critical thinking related to the execution of the study protocol. To develop and implement an integrated Quality Management System or a Risk Based Quality Management plan. - Propose or advise on developing a 'best fit' monitoring strategy based on study needs and identified risks, introducing various centralized monitoring methods, de-centralized trial tools (DCT), and digital health technologies (DHT) in conjunction with traditional monitoring activities.- Steer the development of Quality Tolerance Limit (QTL) monitoring plans to identify systemic errors and adjust strategies to affect change if required. - Engage with cross-functional leads to understand complex indications and risks to the execution of the study protocol. Guide team members to focus on mitigative measures available within their functionality and the scope of work to eliminate, avoid, or reduce the risks related to critical data collection and human safety. Coach and mentor peers on risk assessment methodology and monitoring strategy elements used to ensure high-quality data, reliable analysis, and safety to human subjects. - Collaborate with functional team members in the engineering of study plans ensuring consistency within programs, therapeutic areas, and sponsors within the study scope of work, budget, and protocol content.- Counsel Project Management and Functional Leads on emerging risks, provide analysis, and propose response strategies. Conduct risk re-reviews to determine the level of risk control the mitigative measures offer and suggest further control.

Promote and champion the RBQM methodology and philosophy to internal and external clients. Includes presenting how to leverage technology on the identification of issues or reducing risks towards the goal of quality data analysis. Review budget and contract scope for tasks and provided input for requirements, forecasted assignments completed, and identified over-burn based on study needs. Work in partnership with cross-functional internal and external clients to identify critical processes and data, document risks, define KPIs with tolerance triggers, and propose quality checks within a modified RACT. Facilitate and negotiate potential mitigations to risks determining the best fit based on the risk ranking and with regards to budgetary and timeline constraints. Influence the design and programming of CRF/ EDC based on standards and identified risks by the integration of systems, proposing new technology, and implementing current system functions in new ways to leverage central review. Develop analytical outputs and perform exploratory reviews to identify and document trends and outliers, deciding on which issues need immediate escalation to stakeholders. Provide solutions based on root/cause analysis and metrics. Support and lead cross-functional groups in the comprehension of the data lake, the integration of data systems, facilitate the understanding of data outside the functional group and appreciate system relationships. Create and present scheduled and ad hoc reviews of findings and analysis using visualization tools to cross-functional team members and formal presentations to Clients. Suggest adaptations to data monitoring strategies throughout the life of the study as risks/issues are discovered and based on root cause analysis. Develop and present financial and data mapping training, earning the role of Subject Matter Expert (SME), thus providing one on one mentoring and training on these topics.

Managed clinical trials in a dual PM/CTM role, performing duties for both positions.Forecasted and managed timelines with input from cross-functional groups with both internal and external partners within the contracted budget and scope. Monitored the quality of clinical deliverables and addresses quality issues with the appropriate team member, including reviewing and approving site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues.Managed budget and contract scope, identified 'scope slip,' and worked to re-distribute effort.Liaised with the Project Manager (PM) to facilitate cross-functional team and sponsor communication for proactive, study-wide problem-solving regarding study progress and trial issues during the study. Initiated, motivated, lead and supported the Country Start-Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters.Served as the primary liaison for clinical monitoring issues, interacting with clients, vendors, and other PRA functional areas, escalating as required.

In dual PM/CTM role in late phase group, responsible for time, costs, and quality targets; manage budgets aligned with both company and Client goals, additionally being the operational lead in the day to day and overall management of full service and multi-regional intervention studies.Develop tracking tools and analyze study data to focus on the quality of deliverables and target forecasting, delivering final products on time and within budget. Forecasted and drove study timelines, designing, and programming of Client specific reporting. Perform all tasks at a high level of quality and expertise while inspiring and managing others to perform at the same level concurrently, focusing on the goal of patient/subject safety and well-being.Implemented a reduced monitoring strategy based on critical variables with a central data review component for a Client / Partner.Mentor to SMAs and CRAs to develop skillset and coach on problem-solving skills to become independent decision-makers.

Managed the process of clinical project feasibility studies, setting-up feasibility teams, analyzing data to generate metrics and data-driven reports used by clients as to the direction of their clinical projects.Processed global data to understand how indications are diagnosed and treated to facilitate protocol development within a comprehensive framework. Contributed feasibility study results to the company database to provide for use in future proposals to better submit practical cost proposals based on realistic assumptions.Prepare for, attend, and present feasibility material at bid defense meetings while supporting Business Development with the generation of presentation material for bid-defense meetings.Provide Resource Management and Business Development with feasibility results, e.g., countries, number of sites, subject recruitment projection, to allow timely and adequate staffing proposal.

From CRA I – III and Lead CRAContributed to the culture of quality and process improvement with a focus on streamlining processes adding value to our business, and meeting Client needs.Recognized, exemplified, and adhered to values that centered on a commitment to patients, people, Clients, and performance.Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues.Supported the project management in the planning, forecasting, and reporting for the company and Client needs.Contribute to the review of ICON systems and procedures, as appropriate.Knowledgeable and proficient in study indication to train site and study personnel and to ensure patient safety.Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Conducted, per ICH/GCP and protocol requirements, on-site monitoring visits based on data-driven and milestone-based schedules. Including full site management duties of regulatory, IP accountability, and source data verification. Independently and proactively coordinate the necessary activities required to set up and monitor a study.

Performed Study Coordinator duties for academic clinical trials, duties included regulatory filings, source production, subject facing responsibilities.Developed interventional clinical and retrospective databases to collect study data using SSPS.Compiled outlines and wrote article reviews for use in manuscripts and text chapters.Recruited and coordinated subject study visits with the clinical team, collected data per protcol, and monitoring of clinical studies and trials.Assisted in the development and writing of clinical protocols, designed and organized case report forms and source data forms for ongoing and new research projects.Performed research experiments and facilitated PRO collection on human volunteers following study protocol, IRB standards, and GCP/ICH guidelines.Performed preliminary literary research for use in grants and article submission.Coordinated the filing of and budget reporting of NIH funded grants and industry clinical studies for a multi principal investigator practice.

Facilitated investigator and vendor payment requests per contract.Designed and developed case report forms following protocol, FDA, and GCP/ICH guidelines and assisted in the development of clinical protocols, including monitoring plans and conventions.Collected and tracked all regulatory documents and enrollment reports per SOPs and FDA requirements.Managed daily operations, i.e., accounts payable, employees' schedules, and reimbursements. Implemented, tracked, and facilitate project-specific invoicing to clients in collaboration with the United Kingdom office.Conducted the duties of an 'in-house' monitor, including the review of case report forms, which included query resolution from and to investigational sites and data management.Liaised between traveling monitors, investigational sites, project management, and Client to facilitate. Provided overall clinical support for Phase I-III global clinical trials.