Clinical Study Project Manager

SGS•Richardson, TX

About The Position

The Study Project Manager is ultimately accountable for the planning, execution, issue resolution and communication / communication planning required for successful execution of each assigned clinical study. This includes the creation of a schedule (list of study visits with dates and procedures) for all Richardson clinic studies, using the Scheduler software program and study design information. The Study Project Manager works with all functions to identify needed personnel and other resources, updates schedules as needed to accommodate their availability, sends out notifications of schedule updates, tracks all changes to study schedules, and coordinates the participation of external resources such as physicians as needed. Establish and maintain Project Management project portfolio including templates for project plans, standard updates and communication which include: Establish a detailed project plan for each assigned study to coordinate and track execution with the appropriate functional teams Consult with Investigators and clinic staff on required staff or equipment Provide general timeframes for prospective new studies on request by sales team Send out New Study Information email (NSI) when new or changed study schedule is approved as required Coordinate or Communicate status or updates to project sponsors, or coordinate updates with the relevant Global Key Account Manager (GKAM) Provide reports as requested on number of new studies, study starts per period, etc. Prepare and run a weekly Project Management / Study Scheduling meeting to provide status updates, gather input for scheduling of new studies, escalate issues, and align on client communications / communication plans as needed Use Scheduler software to enter study schedules for signed new studies and high-certainty prospective studies Facilitate discussions for issue resolution by pulling together the needed experts and driving to consensus on the path forward, when required Lead improvements to our study scheduling and execution process based on observed inefficiencies or identified opportunities

Requirements

Bachelor’s degree (science, business, or project management preferred)
6-18 months clinical research experience or equivalent
2+ years of project management experience
Ability to learn and use MS Project or other project management platform
Ability to learn and use proprietary Scheduler software at expert level
Strong understanding of clinic processes and flow, and ability to create study schedules that make good use of resources
Ability to work with others to communicate requirements, build consensus, and overcome problems
Excellent ability to establish priorities with minimal supervision and attention to detail

Responsibilities

Create a schedule (list of study visits with dates and procedures) for all Richardson clinic studies, using the Scheduler software program and study design information.
Work with all functions to identify needed personnel and other resources.
Update schedules as needed to accommodate personnel availability.
Send out notifications of schedule updates.
Track all changes to study schedules.
Coordinate the participation of external resources such as physicians as needed.
Establish and maintain Project Management project portfolio including templates for project plans, standard updates and communication.
Establish a detailed project plan for each assigned study to coordinate and track execution with the appropriate functional teams.
Consult with Investigators and clinic staff on required staff or equipment.
Provide general timeframes for prospective new studies on request by sales team.
Send out New Study Information email (NSI) when new or changed study schedule is approved as required.
Coordinate or Communicate status or updates to project sponsors, or coordinate updates with the relevant Global Key Account Manager (GKAM).
Provide reports as requested on number of new studies, study starts per period, etc.
Prepare and run a weekly Project Management / Study Scheduling meeting to provide status updates, gather input for scheduling of new studies, escalate issues, and align on client communications / communication plans as needed.
Use Scheduler software to enter study schedules for signed new studies and high-certainty prospective studies.
Facilitate discussions for issue resolution by pulling together the needed experts and driving to consensus on the path forward, when required.
Lead improvements to our study scheduling and execution process based on observed inefficiencies or identified opportunities.