• Clinical Study Manager

    Job Locations - | Malaysia
    Posted Date 2 months ago(2 months ago)
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?


    Because we’re hoping you’re here for the latter.


    Who are we?

    We Are PRA.


    We are 15,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.


    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Study Manager, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.


    Still here? Good. Because if this is you, we’d really like to meet you.


    What will you be doing?


    As a Study Manager, you are responsible  for all study management aspects of assigned studies.  The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release.


    The Study Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports. The Study Manager will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.  The Study Manager is a core member of the Study Team.


    The Study Manager works with functional lines to resolve or triage site level issues.  The Study Manager will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.


    What do you need to have?


    Training and Education Preferred:

    • Extensive global clinical trial/study management experience
    • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
    • Prior Experience Preferred:
    • Demonstrated study management / leadership experience
    • Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend


    • Understands how to work with vendors to accomplish tasks
    • Ability to interpret study level data & translate and identify risks
    • Ability to proactively identify & mitigate risks around site level in study execution
    • Understands feasibility of protocol implementation
    • Country level cultural awareness and strong interpersonal skills
    • Keen problem solving skills
    • Excellent communication skills, both written and verbal. Must be fluent in English.
    • Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management


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