Study Manager

Evolution Research Group•Miami, FL

27d

About The Position

The Study Manager (SM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The SM, in concert with the Senior Clinical Team Lead and Principal Investigator, is accountable for achieving successful conduct of the project at the site level by meeting Sponsor on time, with the highest quality. This position will have a variable work schedule, including flexible hours and occasional weekends.

Requirements

Minimum of 2 years of experience in clinical research coordination and project management
Managing project teams through excellent interpersonal communication skills; experience motivating a group to reach a common goal and working collaboratively.
Planning and organizational skills are required.
Must have a thorough knowledge of clinical research concepts, practices, FDA regulations and ICH.
Guidelines regarding drug development phases, clinical research, and data management methods.
Excellent verbal and written communication skills

Responsibilities

Primary site contact for assigned clinical studies.
Lead site clinical team in sponsor study startup and study conduct.
Ensure effective study plans are in place and operational for each trial and work proactively with the Clinical Trial Team to set priorities in accordance with applicable study plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
Proactively manage site level operational aspects of their assigned clinical study and ensure the timely delivery of all requested study logs/spreadsheets to sponsors i.e., Enrollment logs, protocol deviation spreadsheet, AE spreadsheet etc.
Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
Ensure the quality of vendor deliverables, address quality issues with the appropriate team member/s and identify opportunities to improve training, execution, and quality control across the clinical team.
Ensure all site level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.