Regional Study Manager

Top 10 Pharmaceutical Company located in Cambridge MA is seeking 2 Regional Study Managers to join their team.

Compensation is commensurate with experience and education.  Regional Study Manager-Ortho exp as well as hematology experience.

Requirements:
" Bachelor's degree or equivalent regionally (BA or BS Degree: Health / Science or advanced degree preferred)
Experience:BS + 4, MS + 2 Four years of pharmaceutical industry experience (or equivalent), including 2+ years of clinical research experience in the pharmaceutical industry (or equivalent)
One of more years of Clinical Trial management experience in clinical operations or as a clinical scientist preferred


Thorough understanding of the protocol and ICF, SOPs, SPIs, GCP, data privacy laws and applicable regulatory requirements
Knowledge of site / investigator responsibilities
" Awareness of site / study support functional areas
" Understand the internal Wyeth process steps relative to key site management processes
" Understanding of the investigational products(s)

 

I. JOB SUMMARY
" The Regional Study Manager (RSM) serves as the regional project manager for a study from the time of site feasibility and selection through database lock.  As part of the study team, the RSM is accountable for regional study execution and works closely with the Site Manager, CTA, and Operations Specialist to ensure quality, timely study execution and investigator support.  The RSM will serve as a second point of contact for sites as backup for the Site Manager and as a point of escalation for urgent issues.  The RSM will be regional Site Management representation on the study team and serve as the communications conduit between the study team and the site and regional Site Management.

II. JOB RESPONSIBILITIES -

 1.  Accountable for regional study execution 25%
" Drive site-level timelines across the region
" Provide input and approve region specific portions of the monitoring plan as
written by the GTL
o Ensure execution of monitoring plan in region
" Ensure regulatory compliance & GCP adherence across the region
" Assure accurate and reconciled drug accountability across the region
" Maintain a strong knowledge of protocol and all medical and operational aspects to
filter standard questions before reaching other disciplines within the study team
" Develop site level enrollment plans to achieve regional enrollment targets
" Accountable for site qualification and identification and selection input

2. Act as a secondary point of contact (Site Manager is the first) and point of escalation for  15%
site when Site Manager is unavailable or unresponsive
" Medical Questions needing escalation to the RMM or GMM
" Data activities
" On-site tools
" Materials and logistics
" GCP Questions
" Accountable for Investigator Relationship Management for region

3. Represent regional Site Management on study team20%
" Serve as the communications conduit between the study team and the site and
Regional Site Management
" Assist Global Trial Leader (GTL) with Investigator Meeting preparation relative
Regional considerations / separate regional meetings when applicable
" Assist GTL in creating operational training materials specific to a region
" Liaise with Study Team colleagues, CTAs, and Operations Specialist groups as
necessary
" Coordinate with Drug Supply to track and manage regional site supply
" Report site enrollment activities

4. Primary reviewer of trip reports15%
" Ensure completeness of trip report
" Proactively address all operational issues that the site manager is unable to resolve
by liaising with the appropriate study team member, global service, or other individual
as needed
" Assists Site Manager with issue escalation and resolution of open issues

 

5. Provide local input to site selection committees 5%
" Conduct site feasibility
" Accountable for enrolment across the region
" Must take a proactive approach to site planning across the region
" Accountable and responsible for tracking enrollment across the region
" Provides regional input to protocol, CRF design and operational aspects of the
entire study
" Accountable for collaboration with Site Manager to complete Site Qualification
Visit (SQV)

6. Conduct site set up and work with operational specialists (OS) to complete all tasks 5%
" Ensure protocol training of Site Managers and support for region, as applicable
" Provide drug supplies in accordance with import / export rules and regulatory
approval
" Support Site Manager relative SIV
o Also, verify sites have received all study materials and are prepared for SIV
" Set up logistics for region
o Identify vendors
o Ensure contracts are set up and signed

7. Accountable for ensuring high-quality data entered into the system and delivered on time for 5%
the Region
" Compare site information across the region to ensure consistency and recognize
regional issues not apparent at a single site
" Review missing data reports and open query reports for region

8. Liaise with regulatory organizations10%
" Interact with IRB for study start and safety communications
" Interact with central EC/IRB if applicable within the region
" Interact with Ministry of Health (or Local Board of Health)
" Manage site regional regulatory issues
" Correspond with local ethics committees
" Accountable for follow-up and resolution of internal audit and regulatory agency
Inspection issues within a region