New Mandate?

New Leaders Inherit Systems.

They Are Measured on Outcomes.

When you join a CRO in a transformation, recruitment, or digital-trial role, you may inherit:

• an EDC,
• a CTMS,
• eConsent,
• recruitment vendors,
• patient-facing apps,
• DCT tools,
• payment platforms,
• site networks,
• analytics dashboards,
• and dozens of existing workflows.

The temptation is to begin with:

“What tools do we have?”

A better starting point is:

“Where does the participant journey break despite all the tools we have?”

Because the most expensive friction often lives between systems:

• candidate identified but not contacted,
• likely eligible but not screened,
• consented but still blocked from data access,
• milestone completed but not paid,
• patient referred but not activated,
• site ready but waiting on another function.

Those are often the best places for a new leader to create visible impact.

5. The 90-Day Outcome

At the end of your first 90 days, you should be able to say:

“We identified the highest-friction participant handoff, established a baseline, aligned the owners, ran a focused intervention, and can show whether it improved the operating metric.”

That is more valuable than:

“We completed a technology landscape review.”

The playbook is designed around that outcome.

6. Phase 1 — Days 1–15

Map the Participant Journey Before Auditing Vendors

Your first objective is not to evaluate the stack.

It is to understand the real operating journey.

Map:

Candidate identified

→ Contacted

→ Pre-screened

→ Likely eligible

→ Consented

→ Eligibility evidence confirmed

→ Screened → Randomized

→ Study milestone completed

→ Participant reimbursed/paid

Ask at every transition

Who owns the next action?

Which system shows status?

How long does the handoff take?

What permission is required?

What usually causes delay?

What does staff do manually?

What happens when the process fails?

Output

Participant Journey Current-State Map

7. Days 1–15 — Interview the Handoffs, Not Just the Executives

Talk to:

• clinical operations,
• recruitment,
• site operations,
• study managers,
• coordinators,
• data operations,
• quality,
• clinical technology,
• payments/finance,
• patient experience.

Do not ask only:

“What are your biggest problems?” Ask:

“What do you repeatedly have to chase?”

“Where do patients wait?”

“What do you verify manually?”

“Which status requires checking multiple systems?”

“What causes you to call another department?”

“Which step creates the most exceptions?”

These questions reveal workflow friction faster than generic transformation interviews.

8. Days 1–15 — The 10 Handoffs to Inspect First

1.

Protocol criteria → executable screening logic

2.

Candidate data → recruitment queue

3.

Recruitment → site/provider outreach

4.

Pre-screen → consent

5.

Consent → source-data access

6.

Clinical data → eligibility decision

7. Eligible candidate → scheduled screen

8.

Remote/site activity → study status

9.

Milestone completion → payment approval

10.

Withdrawal/change → downstream systems

Red flag

If the organization cannot clearly identify an owner for a transition, that handoff deserves attention.

9. Phase 2 — Days 16–30

Find the Highest-Leakage Handoff

Do not pick the loudest problem.

Pick the problem with the strongest combination of:

• frequency,
• operational cost,
• participant impact,
• sponsor impact,
• feasibility of improvement.

Score each handoff from 1–5 on:

Volume How many participants are affected?

Delay How much time does it add?

Manual effort How much staff time does it consume? Conversion impact Does it reduce progression/randomization?

Participant burden Does it create friction for the patient?

Sponsor visibility Does it affect sponsor confidence?

Fixability Can meaningful improvement be demonstrated within 60 days?

The strongest first pilot is usually not the biggest strategic problem.

It is the highest-value fixable problem.

10. Days 16–30 — Build a Baseline

Before changing anything, establish the current operating metric.

Examples:

Recruitment

Time from candidate identified → contacted

Pre-screen pass rate

Screen-failure rate

Randomized participants per source

Consent/Data

Time from likely eligible → consented

Time from consent → available eligibility evidence

Percentage requiring manual record retrieval

Site operations

Time from candidate → first site action Coordinator hours per enrolled participant

Exception volume

Participant payments

Time from milestone completion → participant paid

Percentage requiring manual exception

Site tickets per payment

Output

Baseline Leakage Scorecard

11. Phase 3 — Days 31–45

Choose One 90-Day Pilot

The pilot should be:

Narrow enough to measure

One study.

One therapeutic area.

One geography.

One workflow.

Important enough to matter

The outcome should connect to:

• enrollment,
• coordinator capacity,
• participant experience,
• payment speed,
• sponsor confidence.

Safe enough to implement

Avoid starting with a core-system replacement.

Choose a workflow that can be improved around the existing stack.

12. The Pilot Selection Matrix

Good first pilot

High pain High frequency Measurable baseline Clear owner Limited integration scope Visible business metric

Poor first pilot

Enterprise-wide Requires replacing multiple platforms No baseline No clear owner Outcome visible only after 12 months

13. Five Strong First-Pilot Options

Pilot 1 — Match-to-Outreach

Metric

Median candidate identification → first meaningful contact Best when

Recruitment leads exist but patients stall before site engagement.

Pilot 2 — Pre-Screen Readiness

Metric

Percentage of candidates arriving at screening with required evidence available

Best when

Screen failure or missing medical data is high.

Pilot 3 — Consent-to-Data Access

Metric

Median consent completion → permissioned clinical data availability

Best when

Consent and source-data workflows are disconnected.

Pilot 4 — Site Handoff

Metric

Median likely-eligible candidate → site action

Best when

Coordinator workload or site response is the bottleneck.

Pilot 5 — Milestone-to-Payment

Metric Median completed milestone → participant payment

Best when

Payment and reimbursement friction is visible.

14. Phase 4 — Days 46–60

Align the Stakeholders Around One Operating Metric

Transformation pilots stall when every stakeholder evaluates success differently.

Choose one primary outcome.

For example:

“Reduce median likely-eligible-to-screening time.”

Then give each stakeholder a supporting metric.

Clinical Operations

Enrollment velocity

Recruitment

Candidate conversion

Site Operations

Coordinator effort

Quality

Control visibility

Technology

Manual handoffs removed Finance

Operational cost

Patient Experience

Wait time/burden

Everyone should be improving the same participant journey.

15. Phase 5 — Days 61–75

This is where many new leaders overcomplicate the initiative.

The goal is not:

“Replace the CTMS.”

or:

“Implement a new DCT platform.”

The goal is:

“Make one participant transition work better.”

For example:

Current state:

Candidate identified in data source → manual email → coordinator review → spreadsheet update → site call.

Target state:

Candidate identified → prioritized workflow event → assigned site owner → status visible → action tracked.

The business outcome matters more than the number of systems replaced.

16. Phase 6 — Days 76–90

Prove the Result and Decide Whether to Expand

At Day 90 compare:

Before

Baseline metric

After

Pilot metric

Difference

Time saved Conversion improved Coordinator hours reduced Participant wait reduced Exceptions removed

Then decide

Stop

Iterate

Expand to more studies

Expand to adjacent workflow

The new leader should emerge from the first 90 days with:

one credible proof point

rather than:

one giant roadmap. 17. The First 90 Days Dashboard

Track:

Participant Progression

Candidate → contact

Contact → pre-screen

Pre-screen → consent

Consent → screening

Screen → randomization

Operational Efficiency

Coordinator hours

Manual handoffs

Exception volume

Systems touched per workflow

Participant Experience

Wait times

Support tickets

Reimbursement delay

Drop-off reasons

Economics

Cost per randomized participant

Cost per screened patient Cost of delay

Site workload

18. Common First-90-Days Mistakes

Mistake 1

Auditing vendors before mapping workflows.

Mistake 2

Choosing a company-wide transformation as the first win.

Mistake 3

Selecting a pilot with no baseline.

Mistake 4

Optimizing software adoption rather than participant outcomes.

Mistake 5

Trying to satisfy every stakeholder with different objectives.

Mistake 6

Reporting “digital transformation progress” instead of measurable operating improvement.

19. The 90-Day Leadership Test

At the end of 90 days, can you answer:

1.

Where is the participant journey most constrained?

2.

What does that constraint cost?

3.

Who owns the handoff?

4.

What baseline did we establish?

5.

What intervention did we test?

6.

What changed?

7.

Should we expand?

If yes, you have a strong transformation story.

Your First Win Should Be Small Enough to Measure — and Important Enough to Matter. Download the editable First 90 Days Playbook and use it to:

• map the participant journey,
• score handoff leakage,
• choose one pilot,
• establish baseline metrics,
• align stakeholders,
• and build your first 90-day operating review.

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Download the First 90 Days Playbook

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THE FIRST 90 DAYS PLAYBOOK FOR PATIENT JOURNEY LEADERS

Find one high-impact participant-journey win fast.

For Heads of Patient Recruitment, DCT, Clinical Innovation, Operational Excellence and Digital Transformation.

PAGE 2 — 90-Day Plan Period Objective Output

Days 1–15 Map participant journey Current-State Map

Days Find highest-leakage Leakage Score 16–30 handoff

Days Select one pilot Pilot Charter 31–45

Days Align stakeholders Shared Metric 46–60

Days Run focused intervention Pilot 61–75

Days Measure and decide Expansion Decision 76–90

PAGE 3 — Participant Journey Worksheet

Handoff Owne System( Median Manual Work Frictio r s) Delay n

Criteria → matching

Match → outreach

Outreach → pre-screen

Pre-screen → consent

Consent → data

Data → screening

Screening → randomization

Milestone → payment

PAGE 4 — Leakage Scoring Score 1–5:

Highest-value fixable handoff:

PAGE 5 — Baseline

Primary metric:

Current baseline:

Target:

Study:

Therapeutic area:

Geography:

Workflow owner:

PAGE 6 — Pilot Charter We will improve:

On:

One study / One TA / One geography / One workflow

Primary metric:

Supporting metrics:

Pilot duration:

Success threshold:

Owner:

PAGE 7 — Stakeholder Map

Stakeholder What They Care About Metric

Clinical Ops

Recruitment

Site Ops

Quality

Technology

Finance

Patient Experience PAGE 8 — Day 90 Review

Baseline

Result

Difference

Operational impact

Participant impact

Financial impact

Decision

• Stop
• Iterate
• Expand
• Scale enterprise-wide later

Found Your First High-Impact Handoff?

Now quantify the economics.

• screen failure,
• coordinator effort,
• enrollment delay,
• manual handoffs,
• participant payment friction,
• and site burden.