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
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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
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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
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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
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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