Resource Planning in Clinical Trials - eudipharm.net Planning in Clinical Trials Catherine Bravo, PhD, PMP Head of Clinical Project Management Global Medical Affairs ... Roles & responsibilities

| 1Resource Planning

Resource Planning in Clinical Trials

Catherine Bravo, Catherine Bravo, PhDPhD, PMP, PMPHead of Head of ClinicalClinical Project ManagementProject ManagementGlobal Global MedicalMedical AffairsAffairsSanofi PasteurSanofi Pasteur

September 2012

Resource Planning | 2

Agenda

● Introduction & definitions● Project definition● Resource definition

● Resource planning● Estimate activity● Identify resource

● Workload management schedule● Resource levelling/ smoothing● Crashing/ fast tracking

● Human Resource Management Process● Develop Project Team● Soft skills


Introduction & definitionsWhat is a project?● Temporary endeavor undertaken to create an unique product, service or

results source PMI


Introduction & definitionsWhat is a project?

● Project triple constraints● Scope: product/service/result is well defined ● Time: Schedules clearly defined ● Cost: budget for creating deliverables/services is limited.


Reason of project failures


Introduction & definitions What is a resource?

● Resource Definition :

”Skilled Human Resource, equipment, services, supplies, commodities, materiel, budget or funds” source PMI

“Any ‘physical’ or ‘virtual’ entity of limited availability that needs to be consumed to obtain a benefit from it.” Source Wikipedia.

● Human Resource : ● identification of resource cost

• Number of Full Time Equivalent (FTE) • Cost of 1 FTE


Resource PlanningDefinition● Estimate activity resources

● Process of estimating the• type• quantities of materiel• Supplies• people • equipment

● to perform each defined activity

● Closely linked to cost planning


Resource PlanningWork breakdown Structure


Resource PlanningTask Attributes template

Cost :

Description :

Responsible :Contributors:

Duration :

Task Attributes

Task Name :

WHEN

WHO

WHAT

HOW MUCH


Resource Breakdown Structure

● A hierarchical structure of resources by resource category and resource type used to identify and analyze project resource assignments.

3d-wbs.blogspot.com


● Construct a Work Breakdown Structure & a Resource breakdown structure for a project which is “ a clinical trial”● Project divided into 3 phases “ prepare” “conduct” &

“report”


Resource PlanningClinical Trial project

Work breakdown structure

Clinical Trial

Prepare Conduct Report

Develop protocol

Develop CRF &

other doc

Ethics Committee submission

Patientsinclusions

Clinical study

Report

Patients Follow

-up

Stat Analysis


Resource PlanningClinical Trial Project

Project RBS

Datamanagement

Project Manager

Statistician

Clinical Trial Leader

Medical writer

Study manager



Resource PlanningClinical Trial Project

Project RBS

Datamanagement

Project Manager

Statistician

Clinical Trial Leader

Medical writer

Study manager

XX

XX XX XX

XX

XX XXXXXXXX

XX

XX

XX

XX XX XX

XXXXXX XX

ClinicalTrial

Prepare Conduct Report

Protocol Otherdoc

regsub Inclusions Stat

Analysis ReportFollow-up

XX XX

XX

XXXX

XX XX XX

XX

RBS



Resource PlanningResource type & availabilities

● What type of resource ?● Skill set● Level of expertise : seniority and experience● Internal / outsourcing

● Resource Calendars (availabilities) ?● Identify resource real availabilities● Estimate need of back up


Resource PlanningTools

● Expert judgment

● Estimated data

● Alternative analysis (make or buy analysis)

● Project Management Softwares● list of most used PM software : MS Project, Primarvera Project

Planner, PNS, OPX2…..www.gestiondeprojet.com


Project planning in Sanofi PasteurOPX2 Gantt Chart


Sanofi Pasteur OPX2 Resource identification● Populate for each CT the needed resources & outsourcing strategy


Workload management schedule

● List all resources and availabilities

● Develop network/PERT diagram & Gantt chart without resources conditions

● Allocate resource to each task

● Analyze resource workload and proceed to resource leveling to eliminate picks and valleys


PERT Chart (Project Evaluation Review Technique) Network diagram, the links between the tasks

Critical path


Gantt Chart, the projection over time


Workload management schedule Resource Histogram

Level of availableresources

Resource Histogram


Workload management scheduleGantt Chart resource allocation

Rare/Unique resource


● Resource-limited Schedule :Adaptation of tasks start date to overcome resource unavailability

● Resource leveling• Delaying or bringing forward the start of certain activities• Extending the duration of certain activities

● Resource smoothing • Attempt to reduce or eliminate resourcing peaks and troughs.

Workload management scheduleResource-limited Schedule


Workload management schedule Resource leveling● Resource conflict resolution => Result in project delay

● Adaptation of project schedule to take into account resource constraints

A 2mo R1 B 3mo R2

C1mo R2

D 1mo R3

Same resource used

A 2mo R1 B 3mo R2

C 1mo R2

D 1mo R3

6 months

7 months


Workload management scheduleResource smoothing● Resource conflict resolution => No impact on project end date

A 2mo R1 B 3mo R2

C1mo R2

D 2mo R3

Same resource used

A 2mo R1 B 3mo R2 D 2mo R3

8 months

8 months

+15d +15d

C15d R2 C15d R2

+15d +15d


● Simplification● 80% of total value created by 20% of functionalities (Pareto principle)

● Crashing● Additional resource added to compress schedule

● Fast tracking● Anticipate start of activities (risk increase)

Workload management scheduleTime limited Schedule


Human Resource Management Process

Acquire Project Team

Project Team Development

Project Team Management

Develop HR PlanIndentify resources

needs


Project Team ManagementTeam building- Tuckman Theory● Team forming

● Functional managers identify resources● Project Kick off meeting with identified resources

● Team Storming● Roles & responsibilities (RACI)● conflicts

● Team norming/performing● Monthly Clinical Trial Team meetings with feed back from all functions

● Team adjourning● Formal project closure● Lessons learn meeting (identify what went well, what were the issues

faced as lessons learned for next project)● Celebrate!!


Human Resource Management ProcessRAM/RACIResponsibility Assignment Matrix (RAM) _ RACI

Project Leader

Project Manager Statistician

Data manager

Medical writer

Study manager

Trial planning C A/R I I I ITrial coordination C A/RProtocol A C C C R CCRF A C I R Cinformed consent A C R CEthics submission A C R

R: ResponsibleA : AccountableC: ContributorI : Informed


Human Resource Management ProcessSoft skills● Conflict resolution techniques

● Confronting* ● Collaborating*● Forcing (competing)● Compromising, mutual acceptance, bargaining● Smoothing, accommodating: de-emphasizing differences, focus on positive aspects● Withdrawing: giving up, ignore the problem

*: win-win● Motivation theories

● Herzberg: Hygiene factors (do not motivate if present but demotivate if absent), motivational factors

● Vroom: expectancy theory, motivation if favorable outcome and reward● McClelland: Achievement theory, need for

• achievement• authority and power• affiliation

● Management by objectives (MBO): SMART objectives● Time and stress management: optimize limited time available, minimize stress● McGregor:

• Theory X (lazy) – Theory Y (willing to do the job)


Human Resource Management ProcessSoft skills

● Motivation theories● Maslow Pyramid : hierarchy of needs


Thank you


Sources

● http://project-management-knowledge.com

● PMBOK Fourth Edition- Project Management Institute


Definitions :OBS/RBS/WBS

● The Organizational Breakdown Structure (OBS) is a hierarchical breakdown of the Department's organizational chart. It identifies how resources are organized within the identifying organization.

● The Work Breakdown Structure (WBS) is a product-oriented hierarchy that organizes and defines the total scope of Project work. This structure defines the work activities, not the staff or other resources who will complete the work.

● The Resource Breakdown Structure (RBS) is a hierarchical breakdown of resources. It defines assignable resources such as personnel, from a functional point of view.

Documents

Resource Planning in Clinical Trials - eudipharm.net Planning in Clinical Trials Catherine Bravo, PhD, PMP Head of Clinical Project Management Global Medical Affairs ... Roles & responsibilities