Working on phase II to IV clinical trials in sites across North America, I managed both traditional and decentralized clinical trials in a variety of therapeutic areas including CNS, metabolic disease, infectious diseases, etc. I worked with a multidisciplinary team from project launch to close-out ensuring timelines were met. I collected, tracked and reported on patient recruitment and study updates from the sites, looking for ways to improve performance when required. On decentralized trials, I prepared and delivered monthly project reports to executives as well as shared an executive summary on a weekly basis. I evaluated study budgets, providing feedback to ensure adequacy with the scope of work. I ensured changes in scope during the project were captured in change orders and reviewed project revenue with the finance team.

Acting as the line manager of a team of 14 clinical data managers and SAS programmers, I was responsible for the day to day operations of the clinical data management department. I would assign resources to different clinical trials, keeping an eye on the team's workload and readjusting as necessary. I represented the data management department at meetings with clients to inform, advise and discuss with them the possibilities for data management for their trials.

Working in collaboration with the Project manager on Early Phase clinical trials, I was responsible for the project management portion of the study which came once the study was finished the clinical portion, i.e., the data management, biostatistical, pharmacokinetic analyses and medical writing portions. In the early stages of the project, I had to evaluate the quote/contract and discuss with clients to ensure that the scope of work for the post-study portion reflected what they needed. I participated in client and team meetings, coordinated with the project team as well as external vendors to ensure the successful completion of the clinical trial. When I identified risks or issues arose, I coordinated with the teams and stakeholders to address them and find suitable solutions.

Working in the Early Phase division of the company, as a Project Manager I was responsible for acting as a liaison between our external clients and the various departments internally. I was responsible for the oversight of the clinical trial from the moment the study was awarded to delivery of the final report and beyond. I established timelines that met the client's needs as well as were operationally viable and worked to keep to those timelines. If unexpected situations arose or risks were identified, I worked diligently with the involved departments to mitigate the impacts on the overall study. Keeping an open line of communication with both my external and internal clients was the key to ensuring successful clinical trials.

During my internship, I wrote protocols for and conducted experiments with real-time PCR reactions, enzyme batch comparisons and experimental method comparisons. Experiments were conducted in a GMP environment adhering to company SOPs. Using the Minitab® software, I developed and tested a «Design of Experiments» (DOE) to optimize the composition of a master mix used in a real-time PCR reaction that was being developed by my team. I analyzed and presented my experimental results at weekly meetings, giving my conclusions and recommendations for further experiments. I wrote a report detailing the experiments performed and analyzing the results obtained during the internship. Finally, I assisted colleagues with their experiments and prepared and aliquoted reagents and targets as needed.

Contract position where I had the role of both study manager and assistant study manager. I planned the logistics, coordinating with various departments, for the completion of successful clinical trials. I evaluated research protocols to determine staffing needs, analyzing and reorganizing staff schedules to optimize efficiency and efficacy. I managed, supervised and re-organized personnel working on the clinical trials; up to 20 staff members on some studies. I evaluated and analyzed scientific research protocols, providing feedback and recommendations. I wrote scientific reports for pharmaceutical companies and regulatory agencies. I performed the final verification of study case report forms prior to the clinical trial. I gave the pre-study briefing to study volunteers as well as dealt with any issues or questions study volunteers might have during the study. I evaluated new company SOPs for accurateness.

I planned the logistics, coordinating with various departments, for the completion of successful clinical trials. I managed, supervised and re-organized personnel working on the clinical trials. I wrote scientific reports for pharmaceutical companies and regulatory agencies. I performed the final verification of study case report forms prior to the clinical trial. I gave the pre-study briefing to study volunteers as well as dealt with any issues or questions study volunteers might have during the study. I evaluated new company SOPs for accurateness.

Quality control of clinical trial data in accordance with GCPs, I worked closely with clinical staff and investigators in order to obtain clarifications and corrections when necessary. I improved the company standard of quality assurance (QA) reports received in the QC department - correction reports received from the QA department were initially from 6-7 pages long and decreased to 3-4 pages while my own QA reports decreased to 1 page. I performed the final verification of blank case report forms prior to clinical trials.

Working on a 3-year cardiovascular study for Pfizer, I worked on every aspect of the study such as data entry, verification of case report forms for accuracy and completeness, writing queries for investigators when clarifications were needed, updating the database when clarifications were received. I was responsible for the final updating of the trial database prior to data being released to Pfizer. I performed literature reviews to collect supporting documentation for report production and collaborated in the writing, editing and verification of company SOPs.