FSP - Study Manager

Fortrea•Durham, NC

3d•Remote

About The Position

We are seeking a Study Manager to be responsible for the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities); may support a single study or multiple studies; and other duties, as assigned. Additional responsibilities may include: Lead a study with limited scope (e.g., Survival Follow-up) Responsible for tracking study timelines and will be proficient in project management tools Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Requirements

Education : BS/BA/MS/Ph.D. ( Life Sciences preferred)
Experience : Minimum 3+ years of relevant clinical research experience in a pharmaceutical company and/or CRO
Pharmaceutical and clinical drug development experience
Experience creating Meeting Minutes
Advanced computer skills, including Microsoft Word, Excel, PowerPoint (MS Project preferred/beneficial)
Excellent oral (including presentation) and written communication, computer/database management, and project management skills
Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs
Ability to resolve project-related problems
Demonstrated organizational skills and the ability to prioritize and multitask
Demonstrated ability to work within a matrix system
TA-specific experience in Oncology

Nice To Haves

MS Project preferred/beneficial

Responsibilities

Responsible for the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities)
May support a single study or multiple studies
Lead a study with limited scope (e.g., Survival Follow-up)
Responsible for tracking study timelines and will be proficient in project management tools
Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives