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    Role of Project Manager in Clinical Trials

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    kandulasatish
    The document discusses the role of a project manager in clinical trials. It provides an overview of key project management concepts like defining a project, different project management methodologies, and phases of project management including planning, managing, and closure. It also outlines specific project management roles and responsibilities in a clinical trial, such as developing project plans and timelines, managing investigator set up, ensuring data quality, and reviewing progress to meet timelines and address any issues. Maintaining ongoing review is important to ensure high quality data and efficient study conduct.

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    Role of Project Manager in Clinical Trials

    Uploaded by

    kandulasatish
    111 views36 pages
    The document discusses the role of a project manager in clinical trials. It provides an overview of key project management concepts like defining a project, different project management methodologies, and phases of project management including planning, managing, and closure. It also outlines specific project management roles and responsibilities in a clinical trial, such as developing project plans and timelines, managing investigator set up, ensuring data quality, and reviewing progress to meet timelines and address any issues. Maintaining ongoing review is important to ensure high quality data and efficient study conduct.

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    The document discusses the role of a project manager in clinical trials. It provides an overview of key project management concepts like defining a project, different project management methodologies, and phases of project management including planning, managing, and closure. It also outlines specific project management roles and responsibilities in a clinical trial, such as developing project plans and timelines, managing investigator set up, ensuring data quality, and reviewing progress to meet timelines and address any issues. Maintaining ongoing review is important to ensure high quality data and efficient study conduct.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    111 views36 pages

    Role of Project Manager in Clinical Trials

    Uploaded by

    kandulasatish
    The document discusses the role of a project manager in clinical trials. It provides an overview of key project management concepts like defining a project, different project management methodologies, and phases of project management including planning, managing, and closure. It also outlines specific project management roles and responsibilities in a clinical trial, such as developing project plans and timelines, managing investigator set up, ensuring data quality, and reviewing progress to meet timelines and address any issues. Maintaining ongoing review is important to ensure high quality data and efficient study conduct.

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    Role of Project Manager in

    Clinical Trials
    AGENDA

    • Project
    • Project Management
    • Project Manager/Lead
    • Roles of PM in Clinical Trial
    What is a project?

    Group of interdependent activities


    intended to achieve a specific
    outcome within defined time period.

    Each project is unique, involves


    certain uncertainties or risks which
    makes it challenging to accomplish.
    Definition
    • Projects are defined differently in different
    pharmaceutical companies.
    • In some companies, a project represents one
    potential medicine no matter how many
    formulations, dosage forms, or indications are
    evaluated.
    • In other companies, each dosage form,
    formulation, and indication studied is
    considered as a separate project.
    • A second aspect of defining projects
    relates to the stage of development at
    which a project is formed.
    • A project may be formed at any stage, from an
    early chemical lead to a medicine that has
    demonstrated activity in Phase II evaluations.
    Cont’d…
    What is Project Management ?

    • A structured approach to manage the elements of


    a project to ensure its success

    How to Manage a Project ?

    • Many formal project management methodologies


    • Vary in scale and complexity
    • Many tools/software to apply in project
    management
    • E.g. MITP – the IBM Project Management Methodology
    • E.g. Microsoft Project – software to manage projects
    Phases in Project Management

    • Project Start-up
    • Planning
    • Managing, Reviewing, Controlling,
    Reporting, Re-planning
    • Project Closure
    Scheduling Project Activities

    • Milestones
    • Gantt
    • Program Evaluation & Review
    Technique ( PERT)
    Milestone schedules
    Milestone schedules

    “Although milestone schedule


    are easy to prepare & review ,
    they do not indicate
    interrelationship between
    activities or any details of the
    project plan.”
    Gantt Charts
    • A Gantt chart is a graphical representation of the
    duration of tasks against the progression of time.
    • Gantt charts are useful tools for planning and
    scheduling projects.
    • Gantt charts allow you to assess how long a project
    should take.
    • Gantt charts lay out the order in which tasks need to
    be carried out.
    • Gantt charts help manage the dependencies between
    tasks.
    • Gantt charts determine the resources needed.
    • Gantt charts are useful tools when a project is
    under way.
    • Gantt charts monitor progress.
    • Gantt charts allow you to see how remedial action
    may bring the project back on course.
    2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0
    IDT a s k N a m e Q tQr t3Qr t4Qr t1Qr t2Qr t3Qr t4Qr t1Qr t2Qr t3Qr t4Qr t1Qr t2Qr t3Qr t4Qr t1Qr t2Qr t3Qr t4Qr
    1 T h e C l i n i c a l T r i a l ( p h I GANTT
    I/III) Chart
    2 P r e -t r ia l s u b m is s io n s
    5 O p e r a tio n a l p la n n in g a n d p r o je c t s ta r t-u p
    9 P r o je c t M a n a g e m e n t
    1 2 In v e s tig a to r s e t-u p
    1 8 S ite m o n ito r in g a n d a u d itin g
    2 2 In v e s tig a to r a n d s ite m a in te n a n c e
    2 5 S tu d y s u r v e illa n c e
    2 8 D a ta p ro c e s s in g a n d d a ta m a n a g e m e n t
    3 4 D a ta a n a ly s is a n d r e p o r t p r o d u c tio n
    4 0 P o s t-tr ia l s u b m is s io n s
    Drawback

    “One of the drawbacks of this


    approach is that it is not suitable
    for most large and complex
    projects and it does not illustrate
    interactions between activities. As
    with the milestone chart, the
    Gantt chart may be used in
    conjunction with more complex
    schedules.”
    PERT ( Program evaluation & Review Technique)
    • is more complex
    • PERT, along with the closely related
    methodologies of Critical Path
    Method and Precedence Scheduling
    are often referred to as network
    methods because they illustrate and
    document how multiple processes
    may be followed in a project
    Cont’d…
    PERT ( Program evaluation & Review Technique)
    • To use the PERT system it is necessary to
    have:
    • A well-defined set of activities that constitute a
    project (usually 20 to several hundred events
    are listed) .
    • Activities that are interrelated with other
    activities and conducted in a predetermined
    order.
    • The ability to designate which activities may
    be initiated and stopped independently of
    each other.
    • An indication of the time required to complete
    each activity or the probability that each
    activity will be successful.
    Selected approaches & problems
    Network diagram
    16 17 18 19 20

    7 22 23 24 25 26

    64 65 66

    28 29 30 31 32

    38

    34 35 36 37

    73 74

    40 41 42 43 44

    9 10 11 12 13 14

    50

    46 47 48 49

    67 68

    58 59 60 61 62

    52 53 54 55 56
    Study Start Up
    2004 2005 2006
    ID T a s k N a m e Q t r Q1 t r Q2 t r Q3 t r Q4 t r Q1 t r Q2 t r Q3 t r Q4 t r Q1 t r Q2 t r Q3 t r
    2 P r e -tria l s u b m is s io n s
    3 C o m p i l e a n d f i n a l i s e i n i t i a l f i l i n g s w R i te h g t , hC e l i nr e O g pu sl a , tMo re y d a u t h o r i t i e s
    4 F i n a l i s e t h e c l i n i c a l d e v e l o p m e n t p l Ca nl i n O p s , M e d
    5 O p e r a tio n a l p la n n in g a n d p r o je c t s ta r t -u p
    6 D e v e l o p a n d m a i n t a i n p r o j e c t a n d o R p ee gr a, Ct i ol i n aO l pp sl a , Mn s e d , S t a t s , D M , M W
    7 F i n a l i s e p r o t o c o l , C R F a n d i n f o r m e d C c l oi nn Os ep ns t , Mf o er md ,s S t a t s , D M
    8 S e t u p p r o je c t - s p e c if ic IT s y s te m s D M ,P r o g ,C lin O p s
    9 P r o je c t M a n a g e m e n t
    10 I m p l e m e n t p r o j e c t a n d o p e r a t i o n a l pR l ea gn s, C l i n O p s , M e d , S t a t s , D M , M W
    11 S u p p o r t a n d m a i n t a i n p r o j e c t - s p e c i f i cD IMT , Ps yr so t ge ,mC sl i n O p s
    Procedure
    • Define Objectives
    • Breakdown of Project until
    manageable units of work/activities
    • Create Schedule
    • Optimistic,
    • Realistic
    • Pessimistic

    • Allocation of resources
    • Delegation of responsibilities
    • Monitor Progress
    • Revise Plan & Reschedule
    Core Competencies of PM
    • Strategic Thinking
    • Planning & prioritizing
    • Proactive & team builder
    • Interpersonal Skills
    • Drive for results & commitment
    • Customer Focus
    • Quality Conscious
    • Confident
    • Communication
    • Consistent
    Why do projects fail?
    • Poor project specification
    • Unrealistic time-scales
    • Time-scales that are too long
    • Inappropriate staff
    • Failure to manage user expectations

    Failing to plan is like planning to fail


    Detailed action plan
    • “Compile and finalise initial filings”

    What do we need?

    • Clinical Trial Application to DCGI


    • Import Licence
    • Submission for Ethics Committee
    Approval
    Clinical Trial Application
    to DCGI
    • What do we need?
    • Protocol & amendments
    • Form 44 – drug details
    • Investigator site details
    • Informed Consent
    • Subject information leaflet
    • Investigator Brochure
    • etc
    Part of the action plan
    Item needed Who will Date Date
    supply? required received

    Information Clinical Team 31st July 30th July


    sheet in Leader
    English

    Translations of Translator & 14th August


    Information Study
    Sheet administrator

    Approval of all Clinical Team 19th August


    information Leader
    sheets
    Investigator Set up
    2 0 0 4 2 0 0 5 2 0 0 6
    I DT a s k N a m e Q t Qr 1 t Qr 2 t Qr 3 t Qr 4 t Qr 1t Qr 2 t Qr 3 t Qr 4t Qr 1 t Qr 2 t Qr 3
    1 2 In v e s tig a to r s e t-u p
    1 3 S e l e c t , r e c r u i t a n d r e p l a c e C i l n i nv Oe s p t is g a t o r s
    1 4 O b t a in s ite c o n tr a c t s C lin O p s
    1 5 C o n d u c t I n v e s t i g a t o r m e e Ct i n l i g n s O p s , S t a t s , D M
    1 6 C o n d u c t p r e - s tu d y v is it s C lin O p s
    1 7 C o n d u c t o n - s i t e i n i t i a t i o n v i sC i tl si n O p s
    Managing the study

    • Ongoing review is important

    1. Ensures data quality


    • Early review ensures proper interpretation
    of the protocol
    • Regular review ensures consistency, and
    continuing attention to detail
    • Regular review ensures efficient data-base
    lock
    • Ongoing review is important

    2. To meet the study timetable


    • Patient recruitment rate should be reviewed
    • Patient RETENTION rate should be reviewed

    • Remedial action can be taken


    • Too slow – more site staff? More centres?
    • Too fast – more data entry staff? Effect on whole
    study?
    Patient recruitment rate

    The theoretical
    Patient Numbers

    ideal
    There are many
    ways to the target

    Time
    Patient recruitment rate
    Patient Numbers

    Action
    required

    More realistic

    Time
    Ongoing Review
    • Communicate progress
    • To sponsor (internal or external)
    • To team members
    • Does data management need to assign new
    resources to deal with increased volumes of
    data?
    • Does slow progress mean data entry staff
    will be needed at the end?
    Project closure

    • Must be planned in detail


    • When is the last patient’s last visit?
    • When will the data be received in
    house?
    • Plan to achieve data base lock
    • Plan to close out sites
    • Account for all the medication supplies
    • Follow up any adverse events
    Close out
    • Internal Meeting
    • What went well?
    • What should we change for next time?
    • Lessons learned
    • External
    • Feed back to investigators
    • Results as soon as available
    • Ongoing commitments
    • Archiving
    • Patient follow up
    Summary
    • Oversee study plan implementation
    • Review/Distribute budgets and associated
    financial procedures
    • Design time-lines
    • Prepare kick-off meeting (discuss roles &
    responsibilities with team members)
    • Organize team meetings (internal & external)
    • Establish lines and flow of communication
    internal as well as external (team members,
    sponsor and outside vendors)
    • Facilitate key deliverables
    • Generate format and content of monthly status
    reports
    • Manage project progress throughout life of study
    Role of PM
    • Project Planning & Control
    • Resource Management
    • Budget Management
    • Building Expertise & Training
    • Quality Management
    • Risk Management
    • Information & Communication
    Management
    • Relationship Management
    • Performance Management

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