August 2024 SOCRA Source Journal - Journal - Page 60
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about the project during
planning and determines
how to execute the project.
Organizing the research
team and project as well
as developing the project
strategy is part of planning.
The project manager
should include the clinical
investigator (or study lead) in
all conversations, especially
to con昀椀rm the scope of work
for the study.
Phase Three, Project
Execution, is the start of the
project. Project execution
includes recruiting and
enrolling participants,
conducting study visits and
procedures, and collecting
data.
Phase Four, Monitoring,
is ongoing during project
execution. This phase
involves controlling the
processes and project
quality. It ensures that the
team is collecting highquality, reliable data.
Along with managing data
collection and evaluating the
data, monitoring includes
managing the staff, budget,
regulatory documentation,
and tracking.
Phase Five, Project
Closeout, is formally closing
a project. This phase involves
submitting 昀椀nal reports, 昀椀nal
data, and 昀椀nal invoices.
The Planning Phase
Planning is a very important
phase in project management
and is the focus of this article.
In the planning phase, the
project manager gathers all
of the information needed to
successfully launch and conduct
the project. This includes
diving into speci昀椀c project
60
requirements, tasks, timelines,
and actions. Planning can
include writing and submitting
documents to the institutional
review board (IRB) and collecting
information on the ancillary
services (i.e. labs, incentives,
personnel) necessary for the
project.
Why plan ahead? The project
manager wants the research
team to complete project tasks
correctly the 昀椀rst time in order
to reduce rework due to poor
planning. Because members of
the research team are generally
excited to get started on a
project, they can begin tackling
assignments without a formal
roadmap or plan. This can make
it dif昀椀cult to get everything in
place before moving forward.
Delays and rework occur when
teams are “building the plane
while 昀氀ying” or the concept of
starting something without all
of the details worked out. When
this happens, it is necessary
for the project manager to
take control and delay project
execution in order to prepare
properly.
How does one do this? The
project manager must ask the
right questions early to have
enough details for appropriate
planning. Sometimes, the project
manager and research team
think that they understand the
project and do not ask enough
questions. While unexpected
events can occur even with
the best planning, the project
manager should try to have as
much detail and strategy for
implementation as possible
prior to executing the study.
This allows the team to have a
process on how to respond to
speci昀椀c scenarios. It is important
SOCRA SOURCE © May 2024
for the project manager and
study team to read the protocol,
note questions, and discuss the
details as a team in order to
determine their understanding
of the project processes. This is
a perfect opportunity as a team
to come up with “what if’s” and
plan out how to handle speci昀椀c
processes in detail as often the
operations of implementing a
protocol are not de昀椀ned when
the project is conceived. Once
this detail is obtained, a formal
strategy can be designed so the
team can get started.
So how does one go about
collecting this information and
taking control of the project?
• A project manager
will develop skills and
experience over time and
will build a system of tools
and resources to move
more seamlessly through
the planning stages. For
new project managers it
is important to reach out
to senior members of the
research team for guidance
during the planning. If there
is doubt regarding the goals
of the project, it is necessary
to ask the research team
member to de昀椀ne the goals
so that everybody is on the
same page.
• Communication is
one of the single most
important aspects of
project management.
Part of communication is
understanding the project
and the tasks assigned to
each team member. This
ensures that everybody
understands what other
team members are doing
and the expected results.
The project manager needs