CHALLENGES INVOLVED IN PROJECT MANAGEMENT
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Transcript of CHALLENGES INVOLVED IN PROJECT MANAGEMENT
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CHALLENGES INVOLVED IN PROJECT MANAGEMENT
Aditi Bose & Khushnoor DastoorPPCE
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Content
• Introduction– Humans & Projects – A comparison– Healthy vs. Unhealthy project– Symptoms of inefficiency
• Project Management– Parameters of Project Success– Challenges– Causes & Treatment
• Summary
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Vital Signs (Health Indicators)
Humans
Temperature
Heart Rate
Respiratory Rate
Blood Pressure
Projects
Commitment
Communication
Consistency
Proactiveness
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Healthy Project
• Clinical Operations • Sites
• Data Management • Biostatistics
SYNCHRONIZEDCommitment, Communication, Consistency & Proactiveness
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Unhealthy Project
• Clinical Operations • Sites
• Data Management•Biostatistics
UNSYNCHRONIZEDCommitment, Communication, Consistency & Proactiveness
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Symptoms
INEFFCIENCY
• Requirements of a regulation being overlooked
• Ignoring risks
• High employee turnover & resources performing under stress
• Disgruntled customers
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Symptoms
INEFFCIENCY
• Shoddy documentation
• Quality checks in haste
• Squeezed timelines
• Unclear priorities
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PROJECT MANAGEMENTParameters of Project Success, Challenges, Causes & Treatment
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Parameters of Project Success
On Scope
On Budget
On Time
On Quality
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Challenges
Managing frequent small changes in Scope
Negotiating skewed perception of small
changes vis-à-vis actual effort required
Bridging the gap between scope and
Budget Building a Limo with a
Volkswagen budget
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Challenges
Controlling Time when input dependent on
others’ output Dealing with procrastination
Ensuring Quality with junior resources on the
team Delivering 100%
Quality with available competencies
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Causes & TreatmentPlanning
Conduct
Close-out
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PLANNING STAGE
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• Ill-defined scope of work
• Forecasting overly optimistic timelines
• Approvals for important planning documents from inappropriate authorities
• ‘Head-in-the-sand’ attitude
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• Involving people with right expertise to review and approve planning documents
• Keeping stakeholders aware of miniscule changes in scope and its impact on cost and timelines
• Identifying risks and planning for back-up
• A robust monitoring process for KRAs with an aggressive focus on timelines at this stage
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CONDUCT STAGE
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• Unanticipated illogical data received from sites for which no edit check was planned
• Unexpected volume of unclean data from the sites
• Site-level differences in completing CRFs leading to consistency issues
• Delay in completion of CRFs and DCFs impacting database lock milestone
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• Implementing a site-level contingency plan based on real-time data pattern
• Educating sites about query and inconsistency possibilities by drafting robust CRF Completion Guidelines
• Sharing site performance reports and associated project risks with stakeholders
• Focusing on analyzability of data and training of DM team
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Site Performance Indicators
1 • CRF Receipt Frequency
2 • Number of queries/re-queries raised
3 • Query TAT and query aging for each site
4 • Data points for which maximum number of queries raised
5 • Illogical application of ND and NA values
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CLOSE-OUT STAGE
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• Data not meeting analysis/regulatory endpoints
• Failure to understand the requirements of the software being utilized for analysis
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• Obtaining clarity on data format requirement for analysis at the planning stage
(ISO 9001 Clause 7.3.2)
• Obtaining Biostats approval for key documents that impact data
(ISO 9001 Clause 7.3.2)
• Sharing data periodically with Biostats to identify systemic data issues early on
(ISO 9001 Clause 7.3.4)
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Highs and Lows are part of Human and Project life!
Ignoring warning signs can be fatal for both!
Summary
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