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clinical affairs project manager resume example with 8+ years of experience

Jessica Claire
, , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Summary

Passionate clinical project manager with a focus on underserved populations by developing strategies within clinical research programs to improve and lead sustainable solutions to clinical evidence generation and dissemination. Maternal and Family Health (MPH) graduate with 13+ years of clinical research experience within medical device, public health, and behavioral-social industries. Experienced in leading cross-functional teams to produce compliant clinical evidence and submissions to notified bodies and competent authorities. Seeking to leverage strong leadership skills to expand beyond individual contributor role.

Skills
  • Project and Program Management
  • Clinical Evidence Generation and Evaluation
  • Product lifecycle strategy (New Product Development to Post-Market Surveillance)
  • Global Regulations for Medical Device including ICH, ISO and EU MDR
  • Sustainable business and life practices
  • Business Unit planning strategy and execution
Experience
04/2022 to Current
Clinical Affairs Project Manager Gcubed Stafford, VA,
  • Lead clinical projects for compliance with protocols, corporate standards and procedures, regulations, and Good Clinical Practice guidelines
  • Lead sustaining clinical activities for post-market product registrations for a $2 billion revenue generating Business Unit
  • Serve on cross-functional project teams as a subject matter expert
  • Develop standardized processes and procedures for Clinical/Medical Affairs
  • Involved in multiple successful global product registrations for Australia (TGA), Japan (PMDA), China (NMPA), Canada (Health Canada), European Union (MDD and MDR), and USA (FDA)
  • Consult on New Product Development (NPD) clinical and regulatory submission strategies and post-market surveillance product lifecycle compliance strategies
  • Manage CEC and DMC/DSMB
04/2020 to 04/2022
Associate Clinical Affairs Project Manager Becton Dickinson, BD City, STATE,
  • Planned and strategized with cross functional teams (R&D, Marketing, Quality, and other business partners) to define, implement, and execute global clinical strategies in support of business objectives
  • Planned, developed, and executed clinical activities (e.g., studies, surveys, committees), to ensure deliverables are completed on time and within budget
  • Developed clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents
  • Developed and reviewed clinical documentation (e.g., CSR, PMCF Report, CER, etc.) for regulatory submissions
  • Interacted with investigational sites, vendors, key opinion leaders (KOLs) and consultants
  • Conducted on-site clinical monitoring activities as needed
  • Collaborated with Medical Monitor, Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs
06/2019 to 03/2020
Research Protocol Specialist Mayo Clinic City, STATE,
  • Coordinated the writing of the protocol/clinical research documents
  • Managed pre-written protocol/clinical research documents through the clinical trial development/implementation process
  • Coordinated study logistics and approvals
  • Communicated with study sites, industry partners, and/or federal agencies regarding protocol submissions
  • Developed clinical trial budgets
  • Provided consultative guidance regarding regulatory and policy requirements to physicians, study staff, and external sponsors
12/2013 to 05/2019
Program Manager University Of California, Los Angeles City, STATE,
  • Oversaw the administration and implementation of National Institutes of Health (NIH) funded clinical trials with budgets up to $1,000,000
  • Liaison between Principal Investigator (PI), NIH Project Manager and Division of Nephrology ensuring day-to-day flow of communications
  • Recruited top talent and was responsible for hiring decisions, and oversight of ten staff direct reports
  • Compiled Institutional Review Board (IRB) submissions and correspondence pertaining to clinical trials and research studies
  • Collaborated with the PI, and UCLA fund-manager on yearly budgetary reporting and management
  • Supported analysis of trial results under the direction of PI and statistician by managing and analyzing data during data collection periods (daily) and providing quality assurance/quality control
  • Coordinated smaller scale research pilot studies/trials (i.e
  • My Transplant Coach, Living Donor Storytelling Library)
  • Lead direct research design, data collection, instrument development, identification of key outcomes, conducting interviews, and focus groups
  • Delegated responsibilities to direct reports including scientific writing of manuscripts, reports, abstract and development of project-related presentations and co-authorship on scientific papers.
Education and Training
Expected in 01/2011
Masters of Public Health Maternal: Family Health
University of Arizona - Tucson, AZ
GPA:
Expected in 01/2006
Bachelor of Arts Anthropology:
San Francisco State University - San Francisco, CA
GPA:

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Resume Overview

School Attended

  • University of Arizona
  • San Francisco State University

Job Titles Held:

  • Clinical Affairs Project Manager
  • Associate Clinical Affairs Project Manager
  • Research Protocol Specialist
  • Program Manager

Degrees

  • Masters of Public Health Maternal
  • Bachelor of Arts Anthropology

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