Is this only for people already managing studies?

No. It is built for CRAs and experienced professionals stepping into accountability, whether from monitoring, site, data or regulatory work.

What do I actually leave with?

Five portfolio artifacts plus a personal promotion trigger map, all built on realistic Phase II and III scenarios and reviewed against defined criteria.

Does this replace a project management qualification?

No. It is role-specific clinical research leadership development, not a generic project management certification.

Is the program accredited?

No. The program itself is not accredited and the certificate of completion is issued by BORAKA only. BORAKA’s founder, Rudy Mallé, is an IAOCR Accredited Clinical Research Trainer and holds Q-IAOCR Trainer accreditation, Trainer #16167194. IAOCR accredits Rudy Mallé as an individual trainer. BORAKA, its programs, courses, assessments, and certificates are not represented as IAOCR accredited, approved, or certified.

How does this align to CTM and CPM roles?

The six modules map to the accountabilities hiring managers test for at Clinical Trial Manager and Clinical Project Manager level: vendor and CRO oversight, risk and escalation, timeline and budget recovery, cross-functional stakeholder communication, inspection readiness and team leadership. CTM work is weighted to single-study delivery and site oversight; CPM work adds program-level budget, scope and portfolio accountability. Both lenses are called out in each module so you can target the one you are moving toward.

Will this get me the CTM title?

No program can guarantee a promotion. This one builds the leadership skill set and the demonstrated evidence hiring managers ask for, then introduces the separately scoped Career Services services if you want search help.

How do I know it is the right tier?

Take the two-minute diagnostic. It recommends a pathway based on your background and target role.

BORAKA Academy program

Leadership Track

A CTM and CPM leadership intensive: vendor oversight, budget and timeline recovery, risk and escalation, stakeholder communication, and a portfolio of leadership artifacts a hiring manager can review.

Take the two-minute diagnostic All programs

Next intake to be announced

Cadence.: 1 to 2 a year

Get notified of dates See all cohort dates

Duration: 6 weeks, live cohort
Contact hours: 12 live sessions, 24 hours of live instruction, 6 modules
Cadence: 1 to 2 cohorts a year
Tuition: $2,997
Target roles: Clinical Trial Manager, Clinical Project Manager, Study Lead

Payment plans available. Fees are confirmed in writing before enrollment.

See cohort dates and fee

Program detail

What this program covers.

Who it is for

CRAs, senior and lead CRAs already doing trial management work without the title, and experienced professionals stepping into CTM or CPM accountability.

Entry expectations

Roughly three or more years in clinical research, typically CRA II, senior CRA or lead CRA
Experience owning study tasks end to end, such as vendor calls, timelines or site escalations
Around 8 to 10 hours a week across the six weeks, including self-paced work

What you leave with

Own vendor oversight, budgets, timelines and escalation at study level
Build five portfolio artifacts that show you already operate as a CTM
Map your promotion path across CRA, Senior CRA, CTM and CPM

Before week one

What happens after you are accepted.

Week 0 sets up your schedule, access and expectations, so the first live session starts on content rather than admin.

Week 0, day 1
Acceptance and cohort confirmation
You receive a written confirmation of your cohort, the live session pattern in your timezone and the weekly time commitment to plan for.
Week 0, day 2
Access to the learning workspace
Your Academy workspace opens with the schedule, the module outline and the criteria each piece of practical work is reviewed against.
Week 0, day 3
Pre-work and systems check
Short pre-work sets a shared baseline, and you test access to the practice environments used during the cohort before week one starts.
Week 0, day 5
Orientation session
A live orientation covers how the weekly capstones work, how feedback is given and what you are expected to produce by the final week.

What you produce by the final week

Five leadership artifacts plus a personal promotion trigger map, each reviewed against defined criteria. Reviewed work becomes evidence you can show. A certificate of completion records attendance and completed work; it is not a competency credential on its own.

Curriculum

Week by week.

Every module pairs live instruction with practical work that is reviewed against defined criteria.

Week 1

The CTM and CPM operating model

What changes when the study outcome is yours
Decision rights across sponsor, CRO, vendors and sites
How hiring managers judge readiness for the title

Week 2

Vendor oversight and CRO governance

Oversight plans tied to key risk indicators
Managing performance against contracted scope
Governance cadence with a CRO and functional vendors

Week 3

Budget, timeline and recovery planning

Study budgets, change orders and burn tracking
Critical path, enrollment planning and recovery scenarios
Resourcing and workload modelling

Week 4

Risk management, escalation and quality

Risk-based quality management in practice
Escalation ladders that hold under pressure
TMF governance and inspection readiness

Week 5

Stakeholder communication and the sponsor, CRO and site triangle

Status reporting that senior stakeholders can act on
Working with medical, data, safety and regulatory functions
Difficult conversations with sponsors, CROs and sites

Week 6

Promotion architecture: CTM to CPM to program lead

Assemble the leadership casebook in BORAKA Academy casebooks
Present artifacts in a CTM interview loop
Introduction into Career Services job-search support

Included

What enrollment includes.

Live instruction from an IAOCR Accredited Trainer
Cohorts of 4 to 8 seats with work reviewed individually
Five leadership artifacts: vendor oversight plan, risk register and escalation ladder, timeline and budget recovery plan, stakeholder comms kit, promotion trigger map
Leadership casebook entry in BORAKA Academy casebooks for reviewed evidence
Recordings and materials retained after the cohort
BORAKA Academy certificate of completion

Rudy Malle personally holds a current Q-IAOCR accreditation as an Internationally Qualified Clinical Research Trainer, Trainer No. 16167194. Every BORAKA Academy program is designed and delivered by Rudy, so learners are trained by an IAOCR Accredited Trainer. A BORAKA Academy certificate of completion is issued by BORAKA only and is not an IAOCR credential. Reviewed evidence still comes from demonstrated work in BORAKA Academy casebooks.

Role pathways

Roles this prepares you for.

Every capstone has a core requirement plus an optional deeper section, so you can weight your work towards the role you are targeting.

Clinical Trial Manager at sponsors and CROsView cohort dates and fee
Clinical Project ManagerView cohort dates and fee
Global Study Lead or Study ManagerView cohort dates and fee
Vendor and alliance manager inside a sponsorView cohort dates and fee
Senior or lead CRA with study-level accountabilityView cohort dates and fee

Portfolio artifacts

What a hiring manager can review.

Each artifact comes out of a weekly capstone and is reviewed against defined criteria before it enters your evidence record.

Week 2
Vendor oversight plan
An oversight plan for a Phase II or III study, tied to key risk indicators and a governance cadence with the CRO and functional vendors.
Week 3
Timeline and budget recovery plan
A recovery plan for a slipping study covering critical path, enrollment scenarios, change orders and resourcing.
Week 4
Risk register and escalation ladder
A study-level risk register with an escalation ladder that holds under pressure, mapped to risk-based quality management.
Week 5
Stakeholder communications kit
Weekly and monthly reporting cadence senior stakeholders can act on, across medical, data, safety and regulatory functions.
Week 6
Promotion trigger map and 90-day plan
A personal promotion map across CRA, Senior CRA, CTM and CPM, with a 90-day plan and the leadership casebook in BORAKA Academy casebooks.

The right fit

Is this you?

A good fit if you

Are a CRA II, senior CRA or lead CRA already doing trial management work
Keep hearing that you need more experience before the promotion
Want clinical operations leadership, not repackaged corporate management training
Want portfolio evidence rather than another certificate
Can hold 8 to 10 hours a week for six weeks alongside a full-time role

Not the right starting point if you

Are new to clinical research, start with Clinical Research Career Mastery
Are moving from site into monitoring, start with Site-to-CRA Bridge
Are looking for a guaranteed promotion rather than demonstrated capability

Included tooling

What you get access to.

Practice environments and job-search tooling that come with enrollment, so the work you do turns into something you can show.

Hands-on EDC access

Work in a real electronic data capture environment to build the oversight artifacts CTM and CPM hiring managers review.

Multi-week hands-on access with guided walkthroughs
Portfolio-ready outputs from real system work

Practice casebooks access

Leadership casebooks and simulations where completed work is scored against defined criteria and becomes your evidence record.

Scenario-based oversight and escalation challenges
Evidence added to your evidence record

Job-search tooling

Résumé, LinkedIn and interview tooling used alongside the program so you can run your own CTM or CPM search when the six weeks end.

Résumé and LinkedIn versions tuned per application
Interview preparation and application tracking

Schedule

Upcoming cohorts.

Dates, application deadlines and format for each cohort. Applying is not an offer of a place; we confirm your cohort by email.

Runs in one or two select cohorts a year. Intentionally selective. A second intake runs only when reviewer capacity allows.

Next cohort being scheduled.

Dates for this program are not published yet. Apply below and we will send the schedule as soon as it is confirmed.

Can’t make this cohort?

Get the next cohort dates before applications open. This is not a waitlist and it does not hold a seat.

Enrollment

How enrollment works.

This program is application based. No payment is taken on the site.

Step 1
Apply
Complete the full application covering your background, target role, availability and funding. It takes about ten minutes and no payment is taken on the site.
Step 2
Review
We read every answer and reply by email within one business day.
Step 3
Enroll
If your application is accepted, you confirm your cohort on an enrollment conversation. Fees and payment plan are set out in writing before you commit, and optional Career Services services can be discussed there without any obligation to add one.

Start the application

About ten minutes. No payment on the site.

Questions

Before you apply.

Still have questions?

Talk to admissions about fit, cohort timing or funding before you apply. We reply within one business day.

Talk to admissions Start application

Role alignment

CTM vs CPM at a glance.

Both tracks run through the same leadership curriculum. This is how the day-to-day scope differs.

Comparison of Clinical Trial Manager and Clinical Program Manager responsibilities
Dimension	CTM	CPM
Scope	One trial, end to end across sites and vendors.	A portfolio or program of related trials.
Primary accountability	Delivery of timelines, quality and study budget.	Cross-study strategy, resourcing and program risk.
Typical stakeholders	Sites, CRAs, vendors, study team leads.	Functional heads, sponsors, governance boards.
Decision horizon	Weeks to months, operational and corrective.	Quarters to years, planning and prioritization.
Evidence you build here	Risk plans, issue escalation, oversight documentation.	Program plans, resource models, governance reporting.

Scope

CTM: One trial, end to end across sites and vendors.

CPM: A portfolio or program of related trials.

Primary accountability

CTM: Delivery of timelines, quality and study budget.

CPM: Cross-study strategy, resourcing and program risk.

Typical stakeholders

CTM: Sites, CRAs, vendors, study team leads.

CPM: Functional heads, sponsors, governance boards.

Decision horizon

CTM: Weeks to months, operational and corrective.

CPM: Quarters to years, planning and prioritization.

Evidence you build here

CTM: Risk plans, issue escalation, oversight documentation.

CPM: Program plans, resource models, governance reporting.

Apply

Apply to Leadership Track.

The full application takes about ten minutes and covers your background, target role, availability and funding. We read every answer and reply within one business day.

Start the application Just send me the dates

We reply within one business day.

Apply to a program

Ask about Leadership Track.

Short form. We reply within one business day with cohort dates, format and next steps. Submitting an application is not an offer of a place.