Offer summary

Qualifications:

Bachelor's degree in a relevant field such as life sciences or healthcare., Strong analytical skills with experience in data review and safety trend analysis., Excellent communication skills for client and stakeholder interactions., Ability to manage multiple projects and resolve complex issues effectively..

Key responsibilities:

Coordinate and review safety data and identify potential issues.

Assist in the creation and review of safety and medical management plans.

Monitor project implementation and escalate any delays or risks to stakeholders.

Serve as the primary point of contact for clinical and data management project teams.

Job description

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 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.

Required profile