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Clinical Trial Manager I Resume Example

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CLINICAL TRIAL MANAGER I
Professional Summary

Experienced Clinical Trial Manager with almost a decade in clinical research and a demonstrated history of working in the pharmaceutical industry.
Thorough knowledge of GCP, regulatory clinical development process. Project Management experience and operational experience in planning/ executing/ reporting clinical trials.
Goal-oriented with a commitment to the delivery of value to team and business objectives.

Skills
  • Clinical trials and research
  • Clinical trial support
  • Clinical Trials Protocols
  • RAVE EDC
  • RAVE X EDC
  • Oracle (TAO)
  • RedCap
  • IMedNet
  • Veeva Vault eTMF
  • Veeva Vault Shared Investigator Portal (SIP)
  • Certified phlebotomist
  • Medical Record Review
  • Vitals, Specimen Collection
  • EKG Administration
Work History
Clinical Trial Manager I, 11/2019 to Current
Alexion Pharmaceuticals, Inc. – Detroit , MI

providing services for Bristol Myers Squibb.

  • Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders.
  • Recognize, exemplify and adhere to the ICON/DOCS values which center around our commitment to People, Clients and performance.
  • Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
  • Coordinates with other internal roles in-country and site feasibility process, including proposal and validation of country study targets
  • Develops country-level patient recruitment strategy & risk mitigation. Coordinates and ensures country-level study enrolment targets and timelines are met
  • Leads problem-solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholders
  • Assessment and set up the of vendors during study start-up period (locally)
  • Investigator Meeting participation and preparation (may include travel)
  • Ensures data entered in Clinical Trial Management Systems is current and complete and access to EDC and vendor systems is available for the Country and clinical trial site personnel
  • Validation of study-related materials (i.e. protocol, ICF, patient material)
  • Responsible for preparing country-specific documents (e.g. global country specific amendment)
  • Prepares materials for Site Initiation Visits
  • Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
  • Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
  • Coordination of database locks and query follow up. Ensures timelines are met.
  • Ensures inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
  • Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
  • Lead study team meetings locally
  • Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
  • Management of Site relationships (includes CRO related issues)
  • Conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
  • Perform site closure activities, including post close-out
  • Act as point of contact for Sites
  • Support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.
  • Maintain client, ICON/DOCS and patient confidentiality.
  • Mentor and train new staff, as assigned
  • Other duties as assigned.
Clinical Research Coordinator C, 05/2017 to 11/2019
Arkansas Urology – North Little Rock , AR
  • Lead coordinator of multiple investigational and observational industry sponsored and PI- initiated studies in various divisions including Preventative Cardiology, Orthopedic Surgery, Pain Medicine, Rheumatology, Medical Genetics, Translational Medicine, and Family and Community Health.
  • Lead coordinator for 10 Gastroenterology studies including sponsor initiate clinical trials, (phase IIb-IV), sponsor and investigator initiated observational studies, and retrospective chart reviews.
  • Responsible for the development of various resources for use on multiple investigational trials within the Clinical Trials Unit.
  • Responsible for the development and review of regulatory submissions for multiple clinical trials and observational studies using local and central IRBs.
  • Responsible for conducting study procedures from start-up to close- out including completion and maintenance of essential regulatory documents, creating source documents, developing databases, and keeping up with study timelines.
  • Manage patient screenings, enrollment, and coordination of site visits (in multiple languages) in addition to facilitating scheduling and performing study visit tasks for multiple studies.
  • Processing and shipment of research samples for Covance, PPD, and MedPace Central Labs.
  • Data entry and management in REDCap, ORACLE, Penn CTMS, and Medidata RAVE and RAVE X systems.
  • Training clinical coordinators and research assistants on study protocols and procedures where necessary.
Clinical Research Coordinator B, 08/2016 to 03/2017
University Of Pennsylvania – City , STATE
  • Lead coordinator on two multi-site studies working with Pulmonary Hypertension and Hepatopulmonary Syndrome (Observational and Clinical Trial).
  • Screened, enrolled, and consented participants for investigational and observational studies.
  • Conducted site visits for multiple studies, responsibilities which included specimen collection (blood and urine), ordering lab tests, pulmonary testing, and cardiac testing, obtaining via interview and electronic medical records and recording medical history, weight and height measurements, and vital signs.
  • Assessed medications and adverse events.
  • Data entry using ORACLE systems.
  • Involved in data analysis and presentation preparation.
  • Translated for Spanish only speaking patients during visits.
  • Translated English consents to Spanish for IRB approval for multiple sites.
Clinical Research Coordinator, 07/2011 to 08/2016
University Of Pennsylvania – City , STATE
  • Responsible for recruitment and retention of study subjects for multi- site ONCOfertility studies.
  • Managed and ensured compliance with all IRB regulatory documents.
  • Managed longitudinal study data using REDCap online database, Velos, and Excel.
  • Blood draw and lab processing.
  • Process and shipment of biological specimen.
  • Communicated with outside study sites.
  • Patient screening and information extraction using EPIC systems.
  • Translated for Spanish only speaking patients during visits.
  • Translated English consents and patient material to Spanish for IRB approval.
Education
Bachelor of Arts: Spanish, 2013
Arcadia University - City, State
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Resume Overview

School Attended

  • Arcadia University

Job Titles Held:

  • Clinical Trial Manager I
  • Clinical Research Coordinator C
  • Clinical Research Coordinator B
  • Clinical Research Coordinator

Degrees

  • Bachelor of Arts : Spanish , 2013

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