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clinical research scientist sr manager resume example with 6+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Summary

A highly motivated clinical research scientist with 5+ years of clinical development and medical affairs experience working in the hematology and immuno-oncology therapeutic areas.

Skills
  • Data management and data review
  • Knowledge of J-Review
  • Organized and detail oriented
  • Team-player with excellent communication skills
  • Work well independently as well as with others
  • Strong problem-solving and troubleshooting skills
  • Possess great analytical skills
  • Knowledge of the GCP and ICH guidelines
  • Hematology
  • Oncology
  • Presentation development
  • Problem-solving
  • Protocols
  • Publications
  • Report Writer
  • Safety
  • Team-player
  • Training materials
Education and Training
Rutgers University New Brunswick, NJ Expected in 2013 Bachelor of Science : Exercise Science and Sports Studies, Applied Kinesiology - GPA :
The George Washington University , Expected in Master of Science : Health Sciences, Clinical and Translational Research - GPA :
Experience
Abbott Laboratories - Clinical Research Scientist, Sr. Manager
Maple Grove, MN, 10/2019 - Current
  • Global CR&D, Multiple Myeloma.
  • Assisted in drafting protocol concept and protocol for phase 1b study.
  • Involved with site feasibility and site selection process for phase 1b study.
Celgene Corporation - Sr. Associate Clinical Research Scientist, Manager
City, STATE, 02/2018 - 10/2019
  • Global CR&D, Lymphoma.
  • Review clinical narratives and data in preparation of the CSR and regulatory submissions of pivotal phase III trial.
  • Draft and review protocols & amendments and informed consent forms.
  • Conduct literature reviews and journal clubs.
  • Prepare site and CRA training materials.
  • Support study committee logistics and presentation development.
Celgene Corporation - Clinical Research Scientist
City, STATE, 09/2014 - 02/2018
  • US Medical Affairs, Hematology.
  • Lead all clinical trial activities for US and global phase III lymphoma studies and a multiple myeloma registry.
  • Create working relationships with external site personnel and internal team coordinating activities across functions (investigators, KOL's, study coordinators, CROs, etc.).
  • Collaborate with team members to form a steering committee for our immuno-oncology portfolio in hematology.
  • Develop immuno-oncology slides for pre-conference internal trainings to medical affairs teams as well as key external stakeholders during steering committee meetings.
  • Partner with heme disease teams to track status of IITs (investigator initiated trials) for immuno-oncology program and produce summary slides for management presentations.
  • Assist in the writing of trial related documents (informed consents, protocols, steering committee charters, etc.) and supporting documents for national IRB submission for medical affairs sponsored trials.
  • Responsible for ongoing clinical review of data and data reconciliation for database locks and data cuts for observational and interventional studies using data listings, patient profiles and safety reports.
  • Prepare data listings and reports through J-Review and Report Writer.
  • Review of AE/SAEs and other relevant safety/laboratory data for events of special interest for understandability, consistency and medical accuracy.
  • Review coding of drugs and adverse events per WHO Drug and MedRA dictionaries.
  • Review of protocol deviations and violations.
  • Issuing and closing manual queries in the clinical database.
  • Write patient narratives and prepare slides using baseline, safety and efficacy outputs for ongoing data monitoring committee (DMC) meetings.
  • Lead and contribute to clinical data review meetings with internal and external team members to identify data review trends and inconsistencies.
  • Lead all activities towards a database lock for submission of a phase III study.
  • Supporting publications plans by generating listings to support key data points.
  • Assist in database user acceptance testing (UAT) to help implement edit checks.
  • Responsible for the trial master file and study documentation according to SOPs/WPDs and GCP/ICH guidelines, ensuring no major audit findings.

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Resume Overview

School Attended

  • Rutgers University
  • The George Washington University

Job Titles Held:

  • Clinical Research Scientist, Sr. Manager
  • Sr. Associate Clinical Research Scientist, Manager
  • Clinical Research Scientist

Degrees

  • Bachelor of Science
  • Master of Science

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