**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Summarized Purpose**:
Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other collaborators 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, using 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 advances 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 increases any delays and/or risks to all collaborators, 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.
**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.
**Knowledge, Skills and Abilities**:
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
**Management Role**:
No management responsibility
**Working Conditions and Environment**:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.