Medical Project Coord

at  Thermo Fisher Scientific

EDUCATION AND EXPERIENCE:

Bachelors degree in Nursing or related Health Sciences (Physician’s Assistant) or licensed RN
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

 Coordinates and reviews safety data, utilizing line listings, company
dashboard(s) and/or other visualization tools. Reviews data for safety trends,
coding consistencies, and potential follow up with investigator sites. Identifies
potential issues and resolves or escalates as appropriate.
 Reviews safety data and may provide summations for safety review meetings.
May review designated sections of aggregate reports.
 May help to create/review safety and medical management plan(s) on studies
(as applicable) and ensures that the processes included in plan documents are
reflective of the contract and services requested.
 May help manage routine project implementation, forecasting and coordination,
including review of metrics and budget considerations.
 Monitors the status of the data review and escalates any delays and/or risks to
all stakeholders, including study leads.
 May present at business development, client, and investigator meetings and
participate in strategy/business development calls.
 Resolves complex problems through in-depth evaluation of various factors and
offers solutions.
 May serve as the primary point of contact for clinical/data management project
teams.
 May assist management in training and mentoring