Cami Jamison Email & Phone Number

Wilmington, NC, US

• Responsible for the overall oversight, harmonization, and management of clinical trials from start up through close out.
• Accountable for the technical, as well as operational aspects of the project to ensure compliance with FDA regulations and other regulatory agencies, SOPs and PPD processes and systems.
• Work across functional areas to identify, assess and convey efficient resolution to issues with sites and vendors, to ensure timely robust data delivery to the Sponsors.
• Oversee project specific training for project team members, site staff and vendor teams.
• Manage clinical trial budget including analyze costs, personnel hours and project needs to determine the most cost effective and efficient means to ensure that all project deliverables meet the client’s need while.

Dublin, Coolock, IE

• Demonstrated successful global project development, global trial and program oversight, and process optimization in trial management. Supervised direct and in-direct reports over three continents.
• Collaborated effectively across multiple global departments to direct the delivery of multiple trials within cost, time, and global quality requirements.
• Contributed to operational development in trial management by providing input and leadership in integrating company SOPs, processes, and working practices so that a continuous clinical quality process improvement was.
• Appointed to collaborate in company initiative to streamline the trial start-up process. Nominated to committee involved in identifying current process, areas for improvement, and new process including updated.
• Led four phase III global trials in parallel to successfully enroll FPFV per timelines for a key (STAR) program for Allergan. Drove cross-functional departments and managed to trial milestones, timelines, metrics.
• Program included 900+ global sites covering six continents, 2300+ global participants randomized, $160M+ operations budget.

Dublin, IE

• Developed a new process for a newly created Inspection Readiness Group within Clinical Operations. Implemented new process across the company and led cross-functional preparations in inspection readiness. Responsible.
• Developed group charter, processes, and tools for newly created functional group and positions.
• Collaborated closely with QA and TMF departments to align processes.
• Motivated cooperation and buy-in from cross-functional groups to follow new process and tools.
• Hired and managed core group of five to implement the day-to-day inspection readiness activities.
• Implemented and directed new process for inspection readiness within Clinical Operations and with cross-functional departments within the company for 6+ submissions.

Dublin, IE

• Demonstrated successful global trial development and process optimization in trial management. Led clinical trials to support the successful registration of new products from start up to trial report. Managed direct.
• Contributed to operational development during company integration by providing input and leadership in company SOPs, processes, and working practices so that a continuous clinical quality process improvement was ensured.
• Led 4-6 phase II-III global trials in different therapeutic areas simultaneously. Drove cross-functional departments and managed to trial timelines, metrics, forecast, and budget.
• Provided input to the operational strategy and into key documents (e.g., trial design, protocol) to ensure trials were operationally executable.
• Led the development and management of the integrated trial operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities (e.g..
• Provided input into and managed the selection, contracting and oversight of CROs and clinical trial related vendors (specifications, country/site selection, start up, conduct, close out, budget/invoices) in.

• Authored drafts of trial synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV trials. Operationally managed one or more clinical trials. Contributed to the preparation of.
• Collaborated with TA management and other functional area input, worked with Project Management to establish and revise timelines for trials.
• Reviewed lab, ECG results of subjects in clinical trials looking for evidence of toxicity (or for evidence at baseline that patients with significant abnormalities were being enrolled inappropriately).
• Interacted with PR&D to ensure that adequate clinical drug supplies were available for clinical trials.
• Evaluated CROs / vendors (subject recruiting services, labs, centralized ECG) for program participation.
• Contributed to the development of documents such as IND, ISE, ISS, NDA.

Switzerland 🇨🇭, CH

• Provided in-house support for large multi-center Phase III clinical trial. Liaison between trial manager, monitors, sites, science, data management and other departments.
• Attended global teleconferences with the Study Manager. Assisted with teleconferences, training, agendas, and meeting minutes.
• Reviewed, tracked, and approved monitoring reports to include informed consents and IRB submissions.
• Managed several “issue” sites and monitored and resolved to turnaround into good standing.
• Created trial tools and materials for sites and monitors (binders, source documents, forms, tools for PK/PD collection). Reconciled trial documents in trial master files to ensure inspection ready.
• Compiled check requests and tracked site payments to assist in budget reconciliation.

US

• Managed global Clinical Research Organizations (CROs), sites, vendors, and internal team for Phase I, II, and III clinical trials (international and domestic). Reviewed, edited, and approved protocols, final trial.
• Designed Case Report Forms (CRFs), reviewed database edit checks, reviewed and approved subject profile design, subject profile review, and created informed consent form templates.
• Reviewed and approved contracts, budgets, invoices, investigational drug labeling and ensured adequate supplies throughout the duration of the trial.
• Planned and conducted investigator meetings, from contract negotiations to presenting trial topics.
• Performed monitoring visits, 100% case report form (CRF) review and source documentation verification, including laboratory tests, diagnostic tests, and ECG tracings.
• Assured adherence to Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference of Harmonization (ICH) guidelines, international regulations and company Standard Operating.

Raleigh, North Carolina, US

• Completed project activities associated with monitoring functions of Phase I-IV clinical research trials while developing an understanding of the drug development process, GCPs, and relevant regulations.
• Managed trial site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and SOPs.
• Created source documents and other trial aids to assist the project team and trial sites.
• Provided and presented therapeutic training to Project Management and team.