| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Hatboro, PA Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLEhttps://LINKEDIN LINK AVAILABLEPROFESSIONAL SUMMARYOrganizational-focused administrative professional with deep clinical research background, excels in customer satisfaction and problem-solving for team process optimization. Committed to driving operational excellence and fostering collaboration to achieve organizational goals effectively. PROFESSIONAL EXPERIENCEICON CLINICAL RESEARCH - Blue Bell, PA 8/2008-05/2024 Clinical Trial Assistant Manager (05/2015-05/2024)Effectively managed Senior and Clinical Trial Assistants (CTA) providing feedback and supervisory support to ensure high performance within the team.Ensured productivity, quality performance, and continuous development while adhering to company policies and procedures.Initiated and implemented project training materials, presentation tools, templates, procedures, documentation practices and processes for the North American (200 staff) and global teams (500 staff). Streamlined task processes for over 500 global CTAs and expedited onboarding new hires by 50%, who were then able to support their teams quickly and effectively while ensuring compliance with training requirements.Swiftly addressed performance issues while maintaining confidentiality in order support the study teams with consistency.Utilized strong functional management skills when coordinating a team of 80 Clinical Research Associates (CRAs), In-House CRAs (IHCRAs), and CTAs for the COVID-19 Vaccine Study. Provided overall document management with daily updates to executive management reports of regulatory document submissions for FDA / Sponsor quality review. FDA approval was received in four months, a record-breaking approval timeline for this groundbreaking study.Monitored, forecasted and evaluated project plans with direct reports' workloads to ensure alignment with assigned tasks, collaborating with Resource Management and Study Team Managers as needed for effective project planning management while adhering to contractual obligations. Utilization numbers increased by 20%, bringing all CTA's overall utilization to 90%.Oversaw the maintenance and timeliness of project documentation, ensuring all regulatory compliance standards were met for each clinical trial.Utilized influence skills to maintain open lines of communication between various departments involved in clinical trials.Streamlined onboarding process for 150 hires. Designated mentors to ensure seamless intake. Held one-on-one meetings that were productive, effective, and supportive. New hires were able to actively contribute to team successes 50% more rapidly than before new process was implemented.Senior Clinical Trial Assistant (08/2010 - 05/2015)Provided administrative and project status tracking support to multiple clinical research teams within dynamic and fast-paced environment with a strong focus on quality to ensure all data monitoring materials collected were accurate, and reliable as outlined in the project specifications.Exhibited strong client assistance skills when addressing inquiries and concerns from sponsors.Created and generated meeting minutes for the team during internal, external, investigator and audit meetings capturing key discussions, decisions and action items for the team.Oversaw project delivery for various clinical trial phases, coordinating with cross-functional teams for successful execution.Utilized clinical study reports to communicate complex clinical trial information to study team and sponsors enhancing transparency and accountability.Assisted in planning, executing, and overseeing eight clinical trials with diverse sponsors, including creating and executing study plans to meet sponsors' expectations of managing sites.Generated monthly study newsletters and PowerPoint presentations for all 40 global sites. This kept sites and sponsors informed on overall enrollment numbers and outlined updates on study deliverables. It also encouraged competition amongst sites to enroll patients, which assisted with the success of the studies.Maintained training compliance records for assigned teams and ensured all study trainings were current.Data management activities completed, many tracking systems utilized to capture patient and site data.Demonstrated high potential in overseeing successful execution of safety reporting, ensuring proper documentation and adherence to regulatory requirements.Submitted regulatory document to the eTMF ensuring quality document review completed prior to submission. Inspection Readiness reconciliation completed on an on-going basis for quality assurance.Established and regularly maintained ongoing communication with over 100 research sites throughout the project.Ascertained when clinical supplies were needed and facilitated vendor orders, ensuring supplies were at sites for patient visits.Therapeutic areas included Cardiology, Non-Hodgkins Lymphoma, Melanoma, and Breast Cancer.Project Assistant - Medical Imaging (08/2008 - 08/2010)Supported Medical Imaging Specialists in managing and organizing medical images of patients enrolled in global clinical trials.Oversaw high volumes of queries for three clinical trials, including expediting query resolutions from sites / CRAs, sending queries to sites for signature, and ensuring timely review and closure of received queries.Performed quality control on offsite assessments / blinded reads by validating accuracy of data entered into the system by Radiologists and Imaging Specialists, which kept the study on track, with timely remediation when needed, and helped meet the deliverables outlined in the Study Plan.Therapeutic areas included Lung Cancer, Breast Cancer, Pancreatic Cancer, and Pancreatic Carcinoid Cancer.CORE SKILLS & COMPETENCIESGlobal Cross-Functional Team Management, Regulatory, GCP, ICH and Compliance Knowledge, Vendor and Site Management, Clinical Drug Supply Management, Standard Operating Procedure (SOP) Review, Business Continuity, Informed Consent, Case Report Forms (CRF), Clinical Data Management, Inspection Readiness, Process Improvement, Leadership, Written and Verbal Communication Skills, Interpersonal Skills, Delegation, Collaboration, Prioritization, Organizational Skills, Mentorship, Attention to Detail, Flexibility and Adaptability, Electronic Clinical Outcome Assessment (eCOA), eConsent, Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Veeva Vault, Florence, Firecrest, SharePoint, Databasics, Workday, Planview, Concur, BOX, MS Office Suite, Zoom |
