Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeSummarized Purpose:Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle.Essential Functions

• 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.

• Should have an undergraduate or graduate in the sciences or related fields/experience (Pharm D, PhD, BS in Science, RN, DDS etc.)
• Minimum, 2-5 years of experience in life sciences or medically related field
• Knowledge of clinical trials process and Good Clinical Practice (GCP)
• Background experience in the therapeutic area for the clinical trial they are supporting

• Strong experience in Perform aggregate trend level reviews & Review investigation product dosing records
• Experience in clinical inputs on risk assessment tool, creating L2/L3 & Centralized Statistical Monitoring (CSM) checks in DMP system and Spotfire visualization requirements
• Knowledge of GCPs for medical oversight of clinical trials and SAE processing
• Knowledge of drug development and safety reporting
• Knowledge of safety data trending to include coding
• Working knowledge of biostatistics, data management and clinical procedures
• Strong problem solving and critical thinking skills
• Good oral and written communication skills
• Good attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances

Thermo Fisher Scientific