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Work Background
Frenova®Senior Clinical Project Manager
Dec. 2023
Trial RunnersClinical Project Manager
Dec. 2022 - Jan. 2024North Dakota, United States
ModernaClinical Trial Manager
Aug. 2022 - Mar. 2023Remote• Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines • Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems • Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs • Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff) • Coordinate Project Team and departmental meetings, including associated documentation • Review and quality check monitoring visit reports
• Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials • Tracking all activities related to clinical trial goals
• Develop and maintain strong, collaborative relationships with key stakeholders within Moderna, its CROs, and clinical sites
RocheClinical Services Project Manager 1
Mar. 2022 - Sep. 2022• Manages multiple clinical and lab services projects of less complex nature from initiation through contract completion. Applies project management skills and experience in delivering projects on time, within budget and with high customer satisfaction. Facilitates cross-functional interactions to complete the assigned projects within the deadline and compliance with pharma services plan. CDx Management Tools, Google Suites, Smart Sheets, Google Docs, SaaS, and Tableau
• • Manages multiple clinical testing and lab services projects from initiation through contract completion under supervision of Program Manager. Acts as primary point of contact to Pharma customers.
• • Performs tactical coordination of timelines for all projects and functions within CDx Pharma Services and: - Develops project plans, establish and coordinates timelines for assigned projects and functions; - Manages execution of cross functional plans and tracks progress of activities; - Identifies gaps, potential bottlenecks or delays and challenge assumptions. • • Oversees and guides day to day activities of sample process flow and accurate reporting of results. Implements / pulls in best practices within the clinical sciences team; fosters continuous improvement by ensuring knowledge and experience exchange • • Guides and manages cross-functional interactions to complete the assigned projects within the deadline. • • Interfaces with resources outside of the company (Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serves as single point of contact with Pharma and Roche clients. • • Manages meeting activities such as setting agendas, organizing meeting time and editing meeting minutes. • • Tracks, maintains and communicates project reports and clinical study data to Pharma and Roche clients.
• • Other duties as assigned by management
Catalyst Clinical Research, LLCClinical Trial Associate
Sep. 2021 - Sep. 2022Remote
FHI ClinicalClincal Project Manager
Feb. 2021 - Sep. 2021Remote
Multicare Institute for Research and InnovationClinical Research Coordinator
Jun. 2019 - Feb. 2021Puyallup, Washington
QTC Management, Inc.Clinical Office Coordinator
Oct. 2017 - Jun. 2019Carmel, Indiana
CovanceAssociate Data Manager
May. 2015 - Apr. 2016Measured customer success by defining operational metrics and reporting results to executive leadership. Kept abreast of current regulations, industry research, documentation, regulatory updates. Designed operating processes for converting and refining raw materials into robust products. All different kind of data work, data check and quality testing need to forward it through secured portal. Worked on query resolutions, data abstracting, data quality assurance as an associate data manager and program manager.
Team Health Care Clinic, PCClinical Assistant
Mar. 2014 - Sep. 2016Point of Care Testing, patient registration, vitals, patient history, insurance verification, biometric health screenings, temperature logs, continuing education, CLIA and OSHA correspondence and guidelines.
Center for Ear Nose Throat and AllergyLead Medical Assistant
Apr. 2010 - Oct. 2017patient education, assisting with endoscopies, biopsies, bilateral myringotomies and other in office surgery procedures, tumor clinic, surgery scheduling, scheduling tests, vitals, assisting with minor procedures, auto-claving instruments, ordering supplies, data entry, triage, prescription refills, and one on one physician contact, wound care and suture removal, blood draw for allergy tests, EMR (Mysis), Allscripts, E Prescribe
Indiana Heart PhysiciansMedical Assistant
Oct. 2004 - Nov. 2009schedule patient appointments and tests. I refer patients to other specialist or their family physicians as needed. My daily duties also include rooming patients, verifying their current medications, writing refill prescriptions, assisting drug reps with needed samples and physician signatures, as well as inventory of all samples. Scheduling cardiac procedures and instructing the patients accordingly, data entry,
assisting in areas that need assisting. Such as, filing, alphabetizing
medical records and fulfilling the needs of our CRMP and Protimes
departments. I also assist the triage nurses as needed with home health orders and patient callbacks, EMR (Hal).
Dr. Susan Holec-IwaskoOffice Manager/Medical Assistant
May. 2003 - Oct. 2009inventory of the office supplies needed to maintain the office's efficiency. Ordering the needed supplies. Copying
all insurance checks and EOB's that came in daily. I also sorted all the
mail. I did payroll hours and calculations every two weeks. I was in
charge of maintaining all patient financial charts as well as medical
charts. I prepared for the next day by pulling patient charts and called
with appointment reminders. Rooming patients was a part of my jobs,
vitals, data entry, performing all sorts on non-invasive test such as
swabbing the throat for strep. Venipuncture and immunizations as well as blood pressure checks. Insurance verifications and physician referrals
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