Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Description
Join Us as a Central Review Manager Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our global team youll have the opportunity to perform centralized report review and approval of PSV SIV IMV and COV reports on assigned projects in accordance with procedural documents and guidelines.
What Youll Do:
Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol site and/or CRA issues or trends noted during the report review process to CTM.
Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report expectations.
Reviews and customizes the Monitoring Report Templates for allocated projects.
Evaluates PI oversight (e.g. protocol adherence) subject safety and study processes in order to assess sites ability to conduct study as ascertained from information noted in monitoring visit reports and associated electronic data systems.
Attends applicable internal Project meetings.
Provides input of forecast estimates for report review activities.
Provides trial MVR status tracking and progress update reports to team as required.
Contributes to company client and federal/local regulatory requirements/audit responses as needed.
May perform support activities to the team as agreed on allocated projects.
Education and Experience Requirements:
Bachelors Degree in a life science-related field or relevant/equivalent combination of education training and experience that provides the individual with the required knowledge skills and abilities.
Prior clinical research experience with a minimum of 2 years on site clinical monitoring.
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills and Abilities:
Good therapeutic area knowledge and understanding of medical terminology by virtue of past training
of a CRA
Ability to attain and maintain a working knowledge of FDA and/or local country regulation and
guidelines ICH GCPs and PPD procedural documents
Ability to successfully complete PPDs Clinical Foundation Training Program (CFP)
Highly effective oral and written communication skills with the ability to communicate effectively with
project team members
Excellent organizational and time management skills
Ability to work in a team or independently or as home based as required
Ability to write clinical monitoring visit reports review or approve them and interpret the information
captured in clinical monitoring visit reports
Ability to extract pertinent information from protocols electronic study data systems CTMS
dashboards and assess risk at site level through interpretation of all these data
Excellent English language and grammar skills
Ability to mentor junior team members as needed
Working Conditions and Environment:
Work is performed in an office.
Exposure to electrical office equipment.
Required Experience:
Manager
Employment Type : Full-Time
Experience: years
Vacancy: 1
